Aesthetic outcomes of non-functional immediately restored single post-extraction implants with and without connective tissue graft: A multicentre randomized controlled trial.

OBJECTIVES: To compare the 1-year aesthetic results of flapless single implants, placed in fresh extraction sockets with bone replacement and immediate provisional restoration with or without a connective tissue graft (CTG). MATERIAL AND METHODS: The present study proposes a partially blinded multicentre parallel randomized controlled trial, where computer-generated tables were used for central randomization to allocate treatments. A total of 59 of the 60 patients screened by eight private practices in Northern Italy fulfilled the inclusion criteria. Immediate implants were placed in a fresh extraction socket with a non-functional immediate provisional restoration with (Test group) or without (Control group) a CTG. The primary outcome variable was the implant Crown Aesthetic Index (ICAI) at the 1-year follow-up. RESULTS: ICAI for the 59 randomized patients (Test group = 31, Control group = 28) at the 1-year follow-up was 4.69 (95% CI = 3.16-6.22) for the Test group and 3.45 (95% CI = 1.83-5.08) for the Control group, without statistically significant difference between the two groups (p = .086). One implant failure was recorded in each group, resulting in an implant survival rate of 96.8% [95% CI = 83.3-99.9] for the Test group and 96.4% [95% CI = 81.7-99.9] for the Control group. Other secondary outcome variables and complication rates were comparable across the two groups. CONCLUSIONS: Within the limitations of the present clinical trial, the results suggested that the adjunct use of CTG is not mandatory to achieve successful aesthetic outcomes for a well-planned immediate implant placement with immediate non-functional provisional restoration in a fresh extraction socket.

The adjunctive use of light-activated disinfection (LAD) with FotoSan is ineffective in the treatment of peri-implantitis: 1-year results from a multicentre pragmatic randomised controlled trial.

PURPOSE: To evaluate possible benefits of the adjunctive use of light-activated disinfection (LAD) in the treatment of peri-implantitis. MATERIALS AND METHODS: A total of 80 patients with at least one implant affected by peri-implantitis defined as at least 3 mm of bone loss on baseline radiographs in the presence of signs of infection (pus exudation and/or soft tissue swelling and/or soft tissue redness) were non-surgically or surgically treated for peri-implantitis and 50% of them were randomly allocated to receive an additional LAD treatment (FotoSan) according to a parallel group design at four different centres. Only one implant per patient was considered. Outcome measures were implant failures, recurrence of peri-implantitis, complications, peri-implant marginal bone level (RAD) changes, probing pocket depth (PPD) changes and number of re-treatment sessions recorded by blinded assessors. Patients were followed up for 1 year after treatment. RESULTS: Five treated patients did not fit the original inclusion criteria: 4 because they were not affected by the present definition of peri-implantitis and 1 due to being treated with antibiotics. However, they were included according to an intention-to-treat-analysis concept. Nine patients of the LAD group were treated surgically versus 10 control patients. After 1 year, 3 patients dropped out, all from the LAD group. One implant treated with the LAD therapy failed versus none of the control group. Four complications occurred: 3 in 3 patients of the LAD group and 1 in the control group. Recurrence of peri-implantitis defined as 2 mm of peri-implant bone loss or more recorded on standardised periapical radiographs was observed in 6 patients, 3 from each group. In total, 29 implants were re-treated 1 to 4 times in the LAD group versus 33 implants 1 to 4 times in the control group; the difference was not statistically significant. Peri-implant marginal bone levels remained stable up to 1 year with no statistically significant differences between groups (0.13 mm favouring LAD therapy; 95% CI of difference -0.47 to 0.72; P = 0.68). PPD significantly reduced in both groups, and at 1 year there were no significant differences between groups (difference 0.19 mm favouring LAD therapy; 95% CI of difference -0.70 to 1.07; P = 0.68). There were significant differences between centres for the number of re-treatment sessions delivered, PPD changes, plaque and marginal bleeding 1 year after treatment, but not for implant failures, complications, RAD changes and recurrence of peri-implantitis. The results did not change when removing the 5 patients who did not match the original inclusion criteria. CONCLUSIONS: Adjunctive use of LAD therapy (FotoSan) with mechanical cleaning of implants affected by peri-implantitis did not improve any clinical outcomes when compared to mechanical cleaning alone up to 1 year after treatment.

The effectiveness of adjunctive light-activated disinfection (LAD) in the treatment of peri-implantitis: 4-month results from a multicentre pragmatic randomised controlled trial.

OBJECTIVES: To evaluate possible benefits of the adjunctive use of light-activated disinfection (LAD) in the treatment of peri-implantitis. MATERIALS AND METHODS: Eighty patients with at least one implant affected by peri-implantitis defined as at least 3 mm of bone loss from the baseline radiographs in the presence of signs of infection (pus exudation and/or soft tissue swelling and/or soft tissue redness) were nonsurgically or surgically treated. A total of 50% were randomly allocated to receive an additional treatment of LAD (FotoSan) according to a parallel group design at four different centres. Only one implant per patient was considered. Outcome measures recorded up to 4 months after treatment were implant failures, complications, probing pocket depth (PPD) changes and number of re-treatment sessions recorded by blinded assessors. Patients were followed for 4 months after treatment. RESULTS: Five treated patients did not fit the original inclusion criteria, 4 because they were not affected by peri-implantitis (as defined in the present study) and one because the patient was treated with antibiotics, however they were included according to an intention-to-treat analysis concept. Nine patients of the LAD group were treated surgically versus 10 control patients. After 4 months, 1 patient dropped out from the LAD group and no implant failed. Fifteen implants had to be re-treated in the LAD group versus 16 implants in the control group, the difference was not significant. Three minor complications occurred: 2 in the LAD group and 1 in the control group. PPD significantly decreased in both groups, and at 4 months there was no significant differences between groups (difference -0.12 mm, 95% CI of difference -0.94 to 0.69, P = 0.77). There were significant differences between centres for number of re-treatments needed, PPD changes, plaque and marginal bleeding 4 months after treatment. The results did not change when removing the 5 patients who did not match the present inclusion criteria. CONCLUSIONS: The use of adjunctive LAD therapy with mechanical cleaning of implants affected by peri-implantitis did not improve any clinical outcomes up to 4 months after treatment, however longer follow-ups are needed to evaluate the possible effect of repeated LAD therapy over time.

Guided bone regeneration with and without a bone substitute at single post-extractive implants: 1-year post-loading results from a pragmatic multicentre randomised controlled trial.

OBJECTIVES: To evaluate whether the adjunctive use of a bone substitute at immediate single implants placed in fresh extraction sockets with a residual buccal bone-to-implant gap of at least 1 mm could improve the aesthetic outcome of guided bone regeneration (GBR). MATERIALS AND METHODS: Eighty patients requiring bone augmentation at a single immediate postextractive implant to improve the aesthetic outcome were randomly allocated to an augmentation procedure using a resorbable barrier alone (GBR group; 40 patients) or a bone substitute plus a resorbable barrier (GBR + BS group; 40 patients) according to a parallel group design at four different centres. Three to 4 months after implant placement/augmentation, implants were loaded with provisional or definitive single crowns. Outcome measures were implant failures, complications, aesthetics assessed using the pink esthetic score (PES), patient satisfaction and peri-implant marginal bone levels, recorded by blinded assessors. All patients were followed up to 1 year after loading. RESULTS: One patient dropped out from the GBR group. Seven (9%) implants failed: 2 (5%) in the GBR + BS group and 5 (12.5%) in the GBR group. Six minor complications occurred in the GBR + BS group versus 2 in the GBR group. These differences were not statistically significant. Just after implant placement/augmentation, mean bone levels were -0.21 mm at GBR + BS implants and -1.92 mm at GBR implants whereas at 1 year after loading they were -1.04 and -1.76, respectively. When comparing the two groups, GBR + BS implants had 0.70 mm more peri-implant marginal bone than GBR implants. Aesthetics was scored by a blinded assessor as statistically significantly better for the GBR + BS group. Patients were equally satisfied. There were no differences between centres regarding the clinical outcomes. CONCLUSIONS: The use of additional an organic bovine bone substitute (Endobon) with resorbable collagen barriers (OsseoGuard) in defects around post-extractive implant improves the aesthetic outcome, though single post-extractive implants might be at a higher risk for implant failures.