Protecting participants in health research: The South African Material Transfer Agreement.

The need to transfer human biological materials (HBMs) across national boundaries has become increasingly important in view of increased biobank and commercial activities globally. In light of South Africa (SA)'s history of colonisation and racial discrimination, coupled with well-known instances of exploitation of research participants in the developing world, it is critical that the management of HBMs from and to other jurisdictions is explored and regulated. Material transfer agreements (MTAs) represent an important point of departure in such a process. This article explores the need for a uniform MTA in SA and discusses some aspects of the recently gazetted national MTA, which provides a framework that can serve as a safeguard for cross-border transfer of HBMs in the absence of the National Health Act's chapter 8 regulations in this regard.

Case report: A medieval case of molar-incisor-hypomineralisation.

INTRODUCTION: Molar-incisor-hypomineralisation (MIH) has been identified in recent years as a condition affecting the first permanent molars and, in some cases, the permanent incisors. Many factors have been suggested as to its aetiology. Examples of MIH have also been reported in skeletal remains in the past. These historical examples have, however, been for unknown individuals. CASE REPORT: A skull that has become available for dental examination that is uncertainly attributed to be that of Lady Eleanor Talbot (c.1436-1468) who ended her life as a Carmelite nun in Norwich (England). The dental findings of the examination showed enamel defects of molar teeth 36 and 46, as well as small areas on other molars, and striations of the enamel of permanent anterior teeth consistent with MIH. There is exposure of the roots of some maxillary teeth with resultant root caries. The presence of areas of enamel decalcification commensurate with 'Turner teeth' on 43 and 44 indicates that there were likely to have been periapical abscesses secondary to dental caries of the primary teeth. In addition, there is occlusal wear of all of teeth with extensive calculus and periodontal exposure of the roots of the mandibular incisors. Failed development or very early ante-mortem loss of premolars 15 and 25 is evident, as well as evidence in the same region of a large abscess cavity with extensive maxillary bone destruction. Healing cribra orbitalia, porosity, which is considered to be an indicator of nutritional stress, is visible on the superior aspect of the left orbit. CONCLUSION: A case of MIH is reported in a skull dating from the mid-15th century.

The conduct of dental research: the protocol, a guide.

BACKGROUND: Research today requires detailed planning to ensure efficient work, to raise funding and to fit into time constraints. AIM: The aim of this article is to provide a broad guidance on the layout and content of a research protocol. METHOD: Years of experience in writing research protocols were used to give guidance on writing, timings, content, layout and successful completion.

Submitting an application for research ethics clearance.

BACKGROUND: Research involving human subjects requires approval by a research ethics committee before commencement. What appears to many researchers to be a daunting task can be relatively easy if approached sensibly. AIM: The aim of this paper is to offer advice to potential applicants for ethics approval of their research. METHOD: The paper provides practical information, based on years of experience, for novice and experienced applicants to a research ethics committee.

Writing scientific papers for publication: "Without publication research is sterile".

BACKGROUND: The publication of basic science and clinical research findings, as well as new clinical diagnosis and treatment techniques, is widely disseminated. These days there is considerable competition to publish so the selection process is even more competitive. AIM: To present advice as to how to enhance the chances of being published and more importantly how to prepare a paper for submission. METHOD: Instructions are presented as to the steps to be taken in writing a scientific manuscript. This covers Introduction, Materials and Methods, Results and Discussion. Guidance is given as to what should be included and also what should be left out. The precision of writing is paramount and scientific text needs to be simple, easily read and translated by those whose day-to-day language is not English. Advice is given on journal selection and how to ensure the best chance of manuscript acceptance.

Congress abstracts: preparing abstracts for submission and successful acceptance.

AIM: To provide guidance on writing congress abstracts for submission and how to increase the chance of acceptance. REVIEW: There is increasing competition for submitted abstracts to be accepted by scientific congresses. Because the facilities or size of a congress may be limited a selection process is often used based upon the quality of abstracts submitted. Accordingly, it is crucial for a researcher to prepare an abstract very carefully to ensure the best chance of acceptance. The approaches to preparing an abstract and the techniques for enhancing quality are reviewed. Suggestions and guidance are given to ensure the production of a well structured, informative and scientifically sound abstract.

Reviewing scientific manuscripts.

AIM: To provide guidance on reviewing scientific manuscripts for publication. REVIEW: Scientific peer review is possibly one of the most important tasks a scientist is asked to do. It carries a great responsibility and needs to be conscientiously and thoroughly carried out. It is most important that a reviewer decides very quickly whether to undertake a review and if so to complete the task. It must at all times be objective, as positive as possible and seen as contributing to the advancement of our knowledge. This review provides suggestions as to best practice in reviewing a scientific manuscript in dentistry. The various aspects of importance: accepting or declining a review, objectivity, approaches to reading and taking notes, assessment of methods, validity and reproducibility of results and evaluating a discussion, are covered in detail and the standards that are required considered. Suggestions are made as to how a review should be reported.

A study of furcation defects at first permanent molars in African mandibles.

INTRODUCTION: This study was undertaken after a personal clinical observation (by AV) that periodontal disease and subsequent attachment loss in the molar root bi-furcation occurs more frequently on the buccal than the lingual aspect of mandibular permanent molars, particularly the first molar. AIMS: The purpose of this investigation was to determine the prevalence and severity of furcation defects on the buccal and lingual aspects of mandibular first molars visually and photographically. MATERIALS AND METHODS: One hundred and six dried human mandibles with neither caries nor restorations on the second premolar or first and second molars were the study sample. Presence and severity of the furcation defects and the position of the mandibular first molar in the mandibular arch were recorded visually. The mandibles were then photographed using a standardized method and the same observations made and compared with those of the visual recording. RESULTS: There were more furcation defects on the buccal than the lingual aspects. Most first molars were within the arch, followed by buccal then lingual. The lowest prevalence, and severity, of furcation defects was when the first molar was within the mandibular arch. CONCLUSIONS: Mandibular first molar furcation prevalence and severity on the lingual was lower than on the buccal aspect, particularly when the first molar was within the arch suggesting that an "anatomically normal" position of the mandibular first molar may have a protective effect. Another observation was that standardized photographs of the mandible may be used for measurements and provides a convenient data base for research.

Protection of human participants in health research - a comparison of some US Federal Regulations and South African Research Ethics guidelines.

In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a structural level research ethics review in South Africa is in many cases equivalent to the US institutional review board (IRB) and Office for Human Research Protections (OHRP) oversight system, is wider reaching, and has no exclusions.

Prospective audit of mandibular fractures at the Charlotte Maxeke Johannesburg Academic Hospital.

OBJECTIVE: This study was a prospective cross-sectional clinical audit of patients with mandibular fractures at the Charlotte Maxeke Johannesburg Academic Hospital. METHODS: Between 1 March and 31 August 2004, patients with mandibular fractures seen by one clinician had their details recorded. RESULTS: The female:male ratio of the study sample of 133 patients was 1:6. Seventy-seven per cent were aged 20-39 years. Most fractures (86%) were the result of interpersonal violence, and 65% were alcohol-associated. Open reduction (75%) was the most common treatment. CONCLUSION: This study had the highest interpersonal violence and open reduction rates of all the studies reviewed.

Dental caries rates in primary teeth in 2002, and caries surveillance trends 1981-2002, in a South African city.

OBJECTIVE: To determine trends in the prevalence and severity of dental caries in 2- to 5-year-old children. BASIC RESEARCH DESIGN: Repeated cross-sectional surveys in 1981, 1983, 1985, 1987, 1989, 1991, 1994, 1997 and 2002. CLINICAL SETTING: Nursery schools in Germiston, South Africa. PARTICIPANTS: Dental caries was diagnosed by calibrated examiners using WHO criteria in 7,185 2- to 5-year-old children whose parents had given informed consent. MAIN OUTCOME MEASURES: Caries prevalence (%), caries experience (dmft). RESULTS: Both caries prevalence and experience showed statistically significant (p < 0.001) fluctuations between study years from 1981 to 2002. A worry is an increase in rates between 1997 and 2002. CONCLUSION: There is a suggestion of a cyclical pattern to the caries rates observed.

Peer-reviewed publication output from South African dental schools 1990-2005.

INTRODUCTION: A study published in 1996 suggested that a limit had been reached for peer-reviewed publication output from South African dental schools. AIMS AND OBJECTIVES: This study was to examine recent trends in publication output from five South African dental schools to compare with the earlier study. METHODS: A PubMed on-line search coupled with a manual search was done for peer-reviewed publications appearing in 1995-2005 from the five dental schools. RESULTS: The literature search identified 610 listings--595 actual publications six of which were listed for two dental schools. Overall there was a slight reduction in number of articles as well as an increase in articles published in South African journals. Within the schools there was also a decline in output. Disciplines producing the publications varied within the schools with dental materials being the most common, There was little difference in the quality of articles indicated by mean CJM scores between the schools. CONCLUSIONS: This study shows that research output has declined beyond the limit speculated in 1996.

Torque removal force for osseointegrated implants--two experimental studies.

OBJECTIVE: To introduce a rabbit-based model for testing the torque removal force (TRF) of implants and to compare the TRF of a series of titanium implants. METHODS: Two experiments were performed at the University of the Witwatersrand. In the first, a Swedish- (SSM-N) or a South African-manufactured (SSM-S) implant was implanted into the tibiae of 12 rabbits and the TRF measured at 1, 3 and 6 months. In the second experiment, the TRF of 4 South African-manufactured titanium implants in the tibia or femur of 32 rabbits were compared at 3 and 6 weeks. The implants were: 1 threaded machined (SSM-S), and 3 surface-enhanced--1 threaded (SLA), 1 threaded tapered (MTT) and 1 pitted (RI). RESULTS: In experiment 1, TRF increased significantly with time (p<0.05) but there was no significant difference between TRF for the South African and Swedish machined-surface implant types. In experiment 2, the TRF of the MTT implant was significantly greater (p<0.0001) than the other 3 types, which did not differ significantly from each other. Time had no significant effect. CONCLUSION: In an internationally used rabbit-based model, South African and Swedish machined-surface titanium implants were equivalent; surface-enhanced implants produced higher TRF, and a tapered implant showed the highest TRF.

What becomes of dental research trainees once they leave the Dental Research Institute? An analysis over 53 years.

The careers of 131 dental research trainees were followed (1954-2007) to establish whether and how they utilised their research training in keeping with clinical research workforce needs. The Dental Research Institute database was used to obtain trainee demographic, teaching and research outputs which were examined according to degree types: PhD (18); MSc (55); MDent (42) and dropout (16). Current careers show that 48% are in exclusive private practice and 15% in exclusive academia with further 15% practitioners having academic links via sessional teaching or research at a dental school. Most (63%) have remained in South Africa but emigration is high amongst the PhD and MSc groups. Forty-one per cent of the cohort is of age

Torque Removal Force for Osseointegrated Implants - Two Experimental Studies

OBJECTIVE. To introduce a rabbit-based model for testing the torque removal force (TRF) of implants and to compare the TRF of a series of titanium implants. METHODS. Two experiments were performed at the University of the Witwatersrand. In the first; a Swedish- (SSM-N) or a South African-manufactured (SSM-S) implant was implantedinto the tibiae of 12 rabbits and the TRF measured at 1; 3 and 6 months. In the second experiment; the TRF of 4 South African-manufactured titanium implants in the tibia or femur of 32 rabbits were compared at 3 and 6 weeks. The implants were: 1 threaded machined (SSM-S); and 3 surface-enhanced - 1threaded (SLA); 1 threaded tapered (MTT) and 1 pitted (RI). RESULTS. In experiment 1; TRF increased significantly with time (p0.05) but there was no significant difference between TRF for the South African and Swedish machined-surface implant types. In experiment 2; the TRF of the MTT implant was significantly greater (p0.0001) than the other 3 types; which did not differ significantly from each other. Time had no significant effect. CONCLUSION. In an internationally used rabbit-based model; South African and Swedish machined-surface titanium implants were equivalent; surface-enhanced implants produced higher TRF; and a tapered implant showed the highest TRF

Equivalency study of histological responses to complete or partial pulpotomies in inflamed baboon immature first permanent molars.

UNLABELLED: Partial pulpotomy is an accepted treatment for traumatised incisor teeth with exposed pulps. Clinical studies in humans suggest that this may also be an acceptable technique for carious exposed pulps in molar teeth, but objective histological evidence to support this perception is lacking. OBJECTIVE: To compare histological responses to complete or partial pulpotomies of inflamed pulps in immature baboon first permanent molar teeth. METHODS: An experimental study in the baboon (Papio ursinus). Pulpitis was induced with fresh Streptococcus mutans placed into occlusal cavities with a small pulpal exposure in 34 first permanent molars of 9 juvenile baboons. After 14 days a pulpotomy, either complete or partial, was performed on the same molars in contra-lateral quadrants using calcium hydroxide covered with IRM and amalgam. After 90 days specimens were harvested and examined under the light microscope with the examiner blind to the treatment. RESULTS: Reaction frequencies in the complete and partial pulpotomy teeth were: dentine bridges 9/16 and 10/16, viable pulp in root canals 10/16 and 13/18, peri-apical abscesses 3/13 and 4/13. Fisher's exact probability test showed no statistically significant rates between the groups. CONCLUSIONS: Complete or partial pulpotomy of inflamed pulps in immature baboon first permanent molars produced comparable reactions.

Waviness of atraumatic restorative treatment (ART) prepared surfaces.

INTRODUCTION: The wave (W) element offers a surface topography assessment method with the potential to yield unique data. AIMS AND OBJECTIVES: This study uses glass ionomer cement specimens prepared with six Atraumatic Restorative Treatment (ART) surface treatments to explore arc- and line-modified waviness of these surfaces to determine if they gave similar results. METHODS: Six specimens (5 x 1.5mm) were prepared for each of the six surface treatments: (1) surface compressed with a Vaseline lubricated finger (Va); (2) Va followed by carving with an excavator(Ca); (3) Ca burnished with a ball burnisher (Bu); (4) surface compressed with the gloved finger lubricated with poly-acrylic acid (Aa); (5) surface cured against a Mylar strip (My); (6) My polished with a white rubber sulcus wheel (Po). After storage in distilled water for seven days at 37 degrees C W(a), W(v), W(p), W(t) was analysed using arc- and line-modifications of the raw profile. The data were analysed using a General Linear Models analysis and Tukey's Studentised range test with P < 0.05. RESULTS: Ca and Bu; Va and Aa; and My and Po formed three groups with descending ranking order for W whether arc- or line-modified. Arc-modified tracing data was unable to statistically distinguish between surface treatments whereas line-modification showed significant differences between treatments for all parameters measured (W(a), W(v0, W(p), W(t)). CONCLUSIONS: Line-modified waviness data was better able to distinguish between surface treatments than arc-modification. Wave offers unique surface topography data having potential value to dental materials researchers.

Measurement of dental restorative material topography.

INTRODUCTION: The tracing of peaks and valleys produced during surface profiling of dental materials are read against a mean line which can be modified in the form of a line or arc. Roughness (R) is commonly used to measure the topography of restorative materials, but the profile (P) value is also generated during the tracing and includes both roughness and waviness of the surface. AIMS AND OBJECTIVES: The purpose of this study was to determine if line and arc modified tracings and R and P surface topography measurements give similar results. METHODS: Thirty six cavities (5 x 1.5mm) were prepared in Perspex discs, restored with Fuji IX, a high strength glass ionomer cement, following the Atraumatic Restorative Treatment (ART) technique and the surface of six cavities were each treated as follows: press finger with vaseline (Va); press finger with polyacrylic acid (Aa); carving (Ca); burnishing (Bu); Mylar strip (My); polishing (Po). Topography was assessed using a profilometer which ran three equidistant tracings (3.6mm) on each surface giving a total of 18 readings for each treatment (n=6). The results of Ra, Rv, Rp, R, and Pa, Pv, Pp, P, for all 6 surface treatments were compared and analysed using ANOVA and Tukey's studentised range test with significance set at P<0.05. RESULTS: Within R + line, R + arc, P + line and P + arc, significant differences were apparent between treatments. Pairwise comparisons showed fewer instances of significant differences between surface treatments when R + line (1 instance of significant difference) was compared to R + arc (2). P + line showed 12 instances of significant differences between surface treatments while P + arc showed no difference. CONCLUSION: Both line and arc tracings gave similar results for R and either may be used in assessing surface roughness. The total deviation of the profile P showed more significant differences between treatments with line than with arc and may be a more sensitive tool when dealing with small sample numbers or subtle differences between surface treatments.

Does mechanical pressure force bacteria into the dentinal tubules of carious and non-carious teeth--an exploratory study.

BACKGROUND: Although many researchers have confirmed bacterial migration within dentine, no evidence was found to show whether bacteria can be easily forced into dentine during caries treatment. OBJECTIVES: This exploratory study was to see if bacteria could be easily forced into dentinal tubules of carious and non-carious teeth using hand excavation and air pressure. METHODS: Two (2) carious and ten (10) non-carious teeth were used. Class I (Black's Classification) cavities were created using rotary instruments in the non-carious teeth, while the carious teeth were excavated using hand instruments to remove the caries. The cavity of one carious tooth was etched and in the other tooth was not. Five (5) of the non-carious tooth cavities were etched, of which, one tooth was also disinfected. The remaining five non-carious teeth were not etched and included one tooth that was disinfected. Bacterial cultures of S. mutans, E. coli and Veilonella were placed in the prepared cavities and hand excavators and air pressure were used in an attempt to force bacteria down into the dentinal tubules. Thereafter, the teeth were fixed, decalcified and prepared for electron or light microscopy. RESULTS: One etched, and one etched and disinfected non-carious tooth showed bacteria in the dentinal tubules. One carious tooth (etched) showed bacterial presence in the dentinal tubules. CONCLUSION: This study shows that it is difficult to force bacteria into dentinal tubules using hand excavation (as in the Atraumatic Restorative Treatment technique) so a definitive study is not indicated.

Global trends in dental fluorosis from 1980 to 2000: a systematic review.

AIM: To determine trends in fluorosis prevalence at water fluoride levels <0.3, >0.3 to <0.7, and >0.7 to 1.4 ppm from 1980 to 2000. METHODS: A systematic review of 55 published articles identified in a Medline search for peer-reviewed articles on fluorosis published from 1 January 1980 to 31 December 2000. The prevalence recorded with any fluorosis index was pooled and the trends over time were determined in the three water concentration categories. RESULTS: The fluorosis prevalence for the three fluoride categories were 16.7, 27.4 and 32.2 percent, respectively. A 16-fold and a 2-fold increase in fluorosis prevalence compared with reported rates in the 1940s was seen in non-fluoridated (= 0.3 ppm F) and fluoridated (>0.7 to = 1.4 ppm F) areas, respectively. There has been an increase in fluorosis prevalence over time in the three fluoride water concentration categories but linear regression analysis showed that none are significantly different from zero. CONCLUSION: This systematic review concurs with recent reports of an increase in fluorosis prevalence in fluoridated and non-fluoridated communities.