Osteotome-mediated sinus floor elevation using an in situ hardening biphasic calcium phosphate bone graft substitute compared to xenograft: A randomized controlled clinical trial.

AIM: To assess osteotome-mediated sinus floor elevation (OMSFE) with simultaneous implant placement using an in situ hardening biphasic calcium phosphate (BCP) compared to xenograft as a control. METHODS: Patient in need for sinus floor augmentation in one or both sinuses were selected for this randomised controlled clinical trial. Sites presenting a residual sinus floor height of 3-6 mm and eligible for OMSFE were randomly assigned to receive either BCP (test) or xenograft particles (control). CBCT scans were performed before and at the time of implant loading (180 days). The difference in sinus floor height gain between the two groups was set as the primary endpoint parameter for equivalence testing. The implant insertion torque (ITV) was recorded and Implant stability quotients (ISQ) was assessed upon implant placement, abutment connection (160 days) and implant loading (180 days). RESULTS: A total of 54 sinus lifts were performed in 42 patients including 12 bilateral cases. Four implants failed (two in each group) and a total of six patients were lost to follow-up. Statistical analysis of sinus floor height revealed no significant differences (p < 0.05) between groups at baseline nor at 180 days after augmentation. There was no statistical difference in sinus floor height gain between the two groups as supported by the 90% confidence intervals of the difference between groups. Good primary implant stability was confirmed in both treatment groups by ITV and ISQ measurements. CONCLUSIONS: Within the limits of this study, it can be concluded that OMSFE using in situ hardening BCP particles results in equivalent sinus floor height gain than using xenograft particles but offers an easier application.

Immediate Implant Placement in Infected Sockets: A Consecutive Cohort Study.

Introduction: Immediate placement of implants in a fresh post-extraction socket is an increasingly popular and established treatment option. However, active infection in the extraction site may adversely affect the outcome of this procedure. This study was designed to assess the clinical results of immediate placement of dental implants in infected extraction sockets using a standardized protocol, which included (a) the use of an Er,Cr:YSGG laser for the decontamination of the infected socket prior to implant insertion, and (b) the utilization of an in situ hardening alloplastic bone graft substitute to augment the gap between the implant surface and the labial plate of bone. Patients and Methods: A retrospective record review was used to identify 68 patients who had implants placed as per the described protocol. A total of 126 implants were placed in 68 patients (65 implants in the maxilla, 61 implants in the mandible). The implants were loaded 136 ± 73 days (mean ± standard deviation; range: 37-400 days) after implant placement. Eight patients (16 implants) were subsequently lost to follow up. Results: 105 of the 110 implants (95.45%) placed immediately in the infected sites using the described protocol survived after prosthetic loading. Conclusion: Immediate implant placement in previously infected sites using the protocols mentioned in our study with laser decontamination of the socket, grafting with an in situ hardening alloplastic bone graft material and non-submerged healing shows a similar survival rate to the published success rates for immediate implants placed in non-infected sites.

Lateral alveolar ridge augmentation procedure using subperiosteal tunneling technique: a pilot study.

BACKGROUND: In this research article, we evaluate the use of sub-periosteal tunneling (tunnel technique) combined with alloplastic in situ hardening biphasic calcium phosphate (BCP, a compound of ß-tricalcium phosphate and hydroxyapatite) bone graft for lateral augmentation of a deficient alveolar ridge. METHODS: A total of 9 patients with deficient mandibular alveolar ridges were included in the present pilot study. Ten lateral ridge augmentation were carried out using the sub-periosteal tunneling technique, including a bilateral procedure in one patient. The increase in ridge width was assessed using CBCT evaluation of the ridge preoperatively and at 4 months postoperatively. Histological assessment of the quality of bone formation was also carried out with bone cores obtained at the implant placement re-entry in one patient. RESULTS: The mean bucco-lingual ridge width increased in average from 4.17 ± 0.99 mm to 8.56 ± 1.93 mm after lateral bone augmentation with easy-graft CRYSTAL using the tunneling technique. The gain in ridge width was statistically highly significant (p = 0.0019). Histomorphometric assessment of two bone cores obtained at the time of implant placement from one patient revealed 27.6% new bone and an overall mineralized fraction of 72.3% in the grafted area 4 months after the bone grafting was carried out. CONCLUSIONS: Within the limits of this pilot study, it can be concluded that sub-periosteal tunneling technique using in situ hardening biphasic calcium phosphate is a valuable option for lateral ridge augmentation to allow implant placement in deficient alveolar ridges. Further prospective randomized clinical trials will be necessary to assess its performance in comparison to conventional ridge augmentation procedures.

Ridge preservation using an in situ hardening biphasic calcium phosphate (ß-TCP/HA) bone graft substitute-a clinical, radiological, and histological study.

BACKGROUND: Post-Extraction ridge preservation using bone graft substitutes is a conservative technique to maintain the width of the alveolar ridge. The objective of the present study was to evaluate an in situ hardening biphasic (HA/ß-TCP) bone graft substitutes for ridge preservation without primary wound closure or a dental membrane. METHODS: A total of 15 patients reported for tooth extraction were enrolled in this study. Implants were placed in average 5.2 ± 2 months after socket grafting. At this visit, Cone Beam CT (CBCT) images and core biopsies were taken. Implant stability (ISQ) was assessed at the insertion as well as at the day of final restoration. RESULTS: CBCT data revealed 0.79 ± 0.73 mm ridge width reduction from grafting to implant placement. Histomorphometric analysis of core biopsy samples revealed in average 21.34 ± 9.14% of new bone in the grafted sites. Primary implant stability was high (ISQ levels 70.3 ± 9.6) and further increased until final restoration. CONCLUSIONS: The results of this study show that grafting of intact post-extraction sockets using a biphasic in situ hardening bone graft substitute results in an effective preservation of the ridge contour and sufficient new bone formation in the grafted sites, which is imperative for successful implant placement.

Minimally Invasive Alveolar Ridge Preservation Utilizing an In Situ Hardening ß-Tricalcium Phosphate Bone Substitute: A Multicenter Case Series.

Ridge preservation measures, which include the filling of extraction sockets with bone substitutes, have been shown to reduce ridge resorption, while methods that do not require primary soft tissue closure minimize patient morbidity and decrease surgical time and cost. In a case series of 10 patients requiring single extraction, in situ hardening beta-tricalcium phosphate (ß-TCP) granules coated with poly(lactic-co-glycolic acid) (PLGA) were utilized as a grafting material that does not necessitate primary wound closure. After 4 months, clinical observations revealed excellent soft tissue healing without loss of attached gingiva in all cases. At reentry for implant placement, bone core biopsies were obtained and primary implant stability was measured by final seating torque and resonance frequency analysis. Histological and histomorphometrical analysis revealed pronounced bone regeneration (24.4 ± 7.9% new bone) in parallel to the resorption of the grafting material (12.9 ± 7.7% graft material) while high levels of primary implant stability were recorded. Within the limits of this case series, the results suggest that ß-TCP coated with polylactide can support new bone formation at postextraction sockets, while the properties of the material improve the handling and produce a stable and porous bone substitute scaffold in situ, facilitating the application of noninvasive surgical techniques.

Clinical evaluation of the Jay Sensitivity Sensor Probe: a new microprocessor-controlled instrument to evaluate dentin hypersensitivity.

PURPOSE: To compare the Jay Sensitivity Sensor Probe (Jay Probe), a new microprocessor-based, pre-calibrated instrument, with well accepted methods used to evaluate sensitivity, i.e. tactile response to the Yeaple Probe, air blast (Schiff scale), and patient responses by Visual Analog Score (VAS). METHODS: Jay Probe assessments were accomplished using several approaches. With a cohort of 12 subjects, two clinical examiners compared the repeatability of the Jay and Yeaple Probes. A second evaluation of both probes was conducted during two independent parallel design clinical studies each enrolling 100 adults with dentin hypersensitivity (DH). In each study, subjects were evaluated for DH responses after twice daily oral hygiene with a negative control fluoride dentifrice or a positive control dentifrice formulated with ingredients proven to reduce sensitivity, i.e. potassium nitrate or 8.0% arginine with calcium carbonate. Tactile evaluations by the Jay and Yeaple Probes were conducted at baseline and recall visits over the 8-week duration of each study. Also evaluated at each visit were responses to air blast and to patient reported DH assessment by VAS. RESULTS: Low inter-examiner variability with no significant differences between replicate measurements (P > 0.05) was observed with the Jay Probe. Consistent with results from previous studies, subjects assigned dentifrices formulated with potassium nitrate or 8% arginine/calcium carbonate demonstrated improvements in Yeaple, air blast and VAS responses in comparison to those assigned the fluoride dentifrice (P < 0.05). Jay Probe responses correlated significantly with all other sensitivity measures (P < 0.05). Differences between these treatments were observed at all post-treatment evaluations using these methods.

Clinical assessment of a new dentifrice with 8% arginine and calcium carbonate on dentin hypersensitivity in an Indian population using a new measuring device: the Jay Sensitivity Sensor Probe.

PURPOSE: To compare a new tactile hypersensitivity testing device [Jay Sensitivity Sensor (Jay) Probe] to three currently available methods of hypersensitivity testing: tactile hypersensitivity by the Yeaple probe, air blast (Schiff's Scale), and their overall hypersensitivity in the absence of any stimuli using the visual analog scores (VAS) during a clinical trial comparing the desensitizing potential of a dentifrice containing 8% arginine, calcium carbonate, and 1,000 ppm MFP (Colgate Sensitive Pro-Relief; Test) against a commercially available fluoride dentifrice (Colgate Cibaca; Negative control). METHODS: This 8-week clinical study enrolled 100 adults with dentin hypersensitivity (DH) to evaluate the desensitizing potential of a dentifrice with 8% arginine, calcium carbonate, and 1000 ppm MFP against a commercially available fluoride dentifrice, on an Indian population. This study included a new DH testing device (Jay Probe) in addition to the current three methods of dentin hypersensitivity testing. Subjects were randomly assigned a dentifrice and were evaluated for DH after 2-week, 4-week and 8-week use of assigned dentifrice. RESULTS: At the end of the 8-week period, the results showed a significant improvement in dentin hypersensitivity in the Test group as compared to the Negative control group. The mean tactile hypersensitivity scores at the 8-week examinations were 39.67 and 38.33 by the Yeaple and Jay Probes, respectively, for the Test group and 15.72 and 15.00 for the Negative control group. These observations were consistent with the other hypersensitivity examinations by air blast and VAS.

Measurement of dentin hypersensitivity with the Jay Sensitivity Sensor Probe and the Yeaple probe to compare relief from dentin hypersensitivity by dentifrices.

PURPOSE: To compare relief from dentin hypersensitivity (DH) after use of dentifrices formulated with potassium nitrate or fluoride. For the study, DH evaluations were conducted with the Jay Sensitivity Sensor Probe (Jay Probe), a novel tactile hypersensitivity instrument, in conjunction with three other DH methods, i.e. Yeaple probe (tactile), air blast, and the Visual Analog Scale (VAS). METHODS: Adults (n = 100) who presented two teeth with DH and met study criteria were enrolled for this double-blind, randomized, parallel, controlled clinical trial conducted in an outpatient setting. DH evaluations at baseline were conducted by the tactile, air blast, and VAS methods. Subjects were randomly assigned a dentifrice formulated with 5% potassium nitrate and 1,000 ppm fluoride (as sodium monofluorophosphate) (Colgate Sensitive toothpaste; Test) or a commercially available fluoride dentifrice with 1,000 ppm fluoride as sodium monofluorophosphate (Colgate Cibaca toothpaste; Negative control). Subjects were recalled for DH evaluations after 4 and 8 weeks of product use. RESULTS: 85 subjects completed the entire study with evaluable results. Both treatments resulted in significant reductions in DH from baseline to all recall visits. In comparison to the Negative control, subjects in the Test group demonstrated significantly greater reductions for all DH evaluations at both 4 and 8 weeks (P < 0.05). Average tactile DH scores at week 8 for the Test and Negative control groups were 36.25 and 15.24 with the Yeaple probe and 35 and 12.43 with the Jay probe. Correspondingly, subjects in the Test group demonstrated significantly greater reductions in air blast and VAS responses for DH than those in the Negative control group (P < 0.05).

A comparison of dentifrices for clinical relief from dentin hypersensitivity using the Jay Sensitivity Sensor Probe.

PURPOSE: To evaluate the clinical relief from dentin hypersensitivity among subjects provided with a dentifrice formulated with 8% arginine, calcium carbonate and 1,000 ppm fluoride [sodium monofluorophosphate (MFP)] in comparison to those issued a commercially available dentifrice containing 1,000 ppm fluoride [as sodium monofluorophosphate (MFP)]. Clinical evaluations for hypersensitivity were performed with a novel tactile hypersensitivity measuring instrument--the Jay Sensitivity Sensor (Jay) Probe--in conjunction with evaporative triggers by air blast (Schiff scale) and Visual Analog Scores (VAS). METHODS: Qualified adults from the Mangalore, India area who presented two teeth with dentin hypersensitivity were enrolled for this double-blind, randomized, parallel, controlled clinical trial conducted in an outpatient clinical setting. At baseline, dentin hypersensitivity was evaluated by the Jay Probe (tactile), air blast and VAS methods. Subjects were randomly issued a study dentifrice and instructed to brush their teeth for 1 minute twice daily with the provided dentifrice. Clinical evaluations for hypersensitivity were repeated after 2, 4 and 8 weeks of product use. RESULTS: 86 subjects (35 males and 51 females) complied with the study protocol and completed the entire study. At each recall visit, both treatment groups demonstrated significant reductions in dentin hypersensitivity from their corresponding baselines (P < 0.05). Subjects assigned the 8% arginine, calcium carbonate and 1,000 ppm fluoride dentifrice demonstrated statistically significant reductions in responses to tactile stimuli, air blast, and VAS responses in comparison to those using the dentifrice containing 1,000 ppm fluoride after 2, 4, and 8 weeks, respectively.

A randomised clinical trial to assess maintenance of gingival health by a novel dentifrice containing 0.1%w/w o-cymen-5-ol and 0.6%w/w zinc chloride.

OBJECTIVES: To assess the ability of 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride dentifrice to maintain gingival health compared to a sodium fluoride control dentifrice. DESIGN: Following a baseline examination, subjects went through a regimen to bring them to a high level of gingival health. This included a professional prophylaxis supported by oral hygiene instruction prior to commencing study treatment. Subjects brushed twice daily for 12 weeks with either the test or control dentifrice. Examinations for gingival inflammation (MGI), bleeding and plaque were performed after 6 and 12 weeks. RESULTS: 224 subjects were included in the efficacy analysis. Relative to the sodium fluoride/ silica control dentifrice group the o-cymen-5-ol/ zinc chloride dentifrice exhibited statistically significant reductions (p<0.0001) in MGI, bleeding and plaque of 12.3%, 18.5% and 13.2% respectively after six weeks and 38.1%, 37.8% and 24.2% after 12 weeks. CONCLUSION: The results of the present clinical study demonstrate that the use of the 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride dentifrice over a 12 week period provides a statistically significant benefit in maintaining gingival health compared to a sodium fluoride control dentifrice.

A randomised clinical trial to assess maintenance of gingival health by a novel gel to foam dentifrice containing 0.1%w/w o-cymen-5-ol, 0.6%w/w zinc chloride.

OBJECTIVES: To assess the ability of 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride gel to foam dentifrice to maintain gingival health compared to a sodium fluoride control dentifrice. DESIGN: Following a baseline examination, subjects went through a regimen to bring them to a high level of gingival health. This involved a professional dental prophylaxis supported by oral hygiene instruction prior to commencing study treatment. Subjects brushed twice daily for 12 weeks with either the test or control dentifrice. Examinations for gingival inflammation (MGI), bleeding and plaque were performed after 12 weeks. RESULTS: 205 subjects were included in the efficacy analysis. Relative to the sodium fluoride/ silica control dentifrice group the o-cymen-5-ol/ zinc chloride gel to foam dentifrice exhibited statistically significant reductions (p<0.0001) in MGI, bleeding and plaque of 32.2%, 26.3% and 20.7% respectively after 12 weeks. CONCLUSION: The results of the present clinical study demonstrate that the use of the 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride gel to foam dentifrice over a 12 week period provides a statistically significant benefit in maintaining gingival health compared to a sodium fluoride control dentifrice.

A clinical investigation of the tooth whitening efficacy of a new hydrogen peroxide-containing dentifrice.

OBJECTIVE: The objective of this four-week, double-blind clinical study was to assess the tooth whitening efficacy of a new dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base (Test Dentifrice), relative to that of a control dentifrice containing 0.243% sodium fluoride in a silica base (Control Dentifrice). METHODOLOGY: Following a baseline oral soft tissue examination and tooth shade assessment using the Vita Shade Guide, qualifying adult male and female subjects from the New Delhi, India area were randomized into either the Test or Control Dentifrice group. The two groups were balanced for baseline mean Vita Shade Guide rank scores. All subjects were provided with their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for two minutes twice daily (morning and evening), using only the dentifrice provided, and to refrain from using any other oral hygiene products for the entire four weeks of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Oral soft tissue and tooth shade evaluations for each subject were repeated after two and four weeks of product use. RESULTS: Forty-four (44) subjects complied with the protocol and completed the entire study. At the two- and four-week examinations, the Test Dentifrice group had statistically significant mean shade rank score reductions of 4.04 and 5.17, respectively, compared to baseline (p < 0.05), while the Control Dentifrice had respective reductions of 0.41 and 0.53, which were also statistically significant. The mean shade rank reductions in the Test group compared to those in the Control group at two and four weeks were 3.63 and 4.64, respectively, and were statistically significant (p < 0.05). CONCLUSION: A new whitening dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride and sodium tripolyphosphate has significant tooth whitening effectiveness, producing a mean shade rank score reduction from baseline of 5.17 after four weeks' use.