Reconstructive Surgical Therapy of Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

Reconstructive Surgical Therapy of Peri-implantitis: 3-year Results of a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769609
• Other study ID #: GUDHKAEK.2021.01/4
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: February 12, 2021

Study information

• Verified date: February 2021
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Various treatment protocols of peri-implantitis involving surgical therapies with open flap debridement procedures, resective or reconstructive modalities have been documented to achieve variable success. Surgical non-reconstructive approaches have been suggested to have limited effectiveness in terms of the resolution of inflammation in the long term. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. The aim of this study was to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or concentrated growth factor (CGF). A total of 52 patients who had at least one implant diagnosed with peri-implantitis and needed to be scheduled for reconstructive therapy of a peri-implant infrabony defect were included. Peri-implantitis case was defined as increased probing depth (PD) compared to previous examinations with bleeding on probing (BOP) and/or suppuration and radiographic evidence of peri-implant bone loss beyond crestal bone level changes resulting from initial bone remodeling. The patients were randomly assigned to receive a bone substitute filling in combination with either CM or CGF. Intrabony components were filled with a bone substitute (BioOss spongiosa granules; Geistlich, Wolhusen, Switzerland) and covered with a CM (Bio-Guide, Geistlich Biomaterials) or CGF membrane. The plaque index (PI), gingival index (GI), BOP, PD, clinical attachment level (CAL), mucosal recession (MR) and radiographic vertical defect depth (VDD) values were evaluated at 1 and 3 years postoperatively.

Description:

Peri-implantitis is a plaque-associated pathological disease affecting the soft and/or hard tissues surrounding a dental implant and clinically characterized by bleeding on probing (BOP) and/or suppuration (Supp), increased probing depths (PDs) and/or mucosal marginal recessions (MRs) in addition to radiographic marginal bone loss (MBL) compared to previous examinations. Considering the increasing numbers of patients undergoing restorative treatment through dental implants and the corresponding increase in the prevalence of peri-implantitis, it is imperative to perform effective treatment methods for the management of these conditions. On the basis of evidence, the most reliable and predictable treatment of peri-implantitis has not yet been described, moreover, if the disease is left untreated, it progresses in a non-linear accelerating manner. Hence, peri-implantitis has been considered to be a major, unpredictable and growing problem for clinicians.

Various treatment protocols of this challenging problem involving non-surgical approaches and surgical therapies with open flap debridement procedures, resective surgeries, or reconstructive modalities, which include the use of bone substitutes with or without a membrane, decontamination methods of implant surfaces, antimicrobial prescriptions whether to use submerged or non-submerged techniques, have been proposed. Although non-surgical interventions have been reported to be effective in reducing BOP and PDs in peri-implantitis sites, these therapies have appeared to be unpredictable for the management of peri-implantitis, especially in most severe cases. As another treatment option, surgical non-reconstructive approaches, i.e. open flap debridement and surface decontamination alone, have been suggested to have limited effectiveness in terms of the resolution of inflammation for the long-term outcomes. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. Several surgical augmentative therapy studies, including the use of bone substitutes with or without barrier membranes have demonstrated significant clinical and radiographic improvements for at least 3 years, especially in well-contained (three- or four-wall) intrabony defects. A systematic review evaluating long-term outcomes of reconstructive therapy for the management of peri-implantitis showed a mean PD reduction of 3 mm and a radiographic gain of 2.4 mm in bone level. However, as indicated by the last EFP Workshop, no evidence to support the superiority of a specific material, product or membrane in terms of long-term clinical outcomes of a reconstructive approach has been found. It has been strictly recommended that identification of peri-implantitis therapy success and disease resolution in the long-term management are required to allow adequate assessment of stable treatment outcomes.

Because of many studies indicating that growth factors have provided to transiently stimulate cells locally, accelerate angiogenesis, promote proliferation, differentiation, and regeneration, the additional use of them in the management of peri-implantitis has been proposed to improve the clinical outcomes and enhance soft and hard tissue regeneration. A recent systematic review and meta-analysis has been suggested that growth factors might be associated with better outcomes with regard to PD and BOP, whereas, they did not reveal statistically significant evidence for yielding additional benefits in the treatment of peri-implantitis. A randomized clinical trial (RCT) on the reconstructive surgical treatment of peri-implantitis evaluating concentrated growth factor (CGF) used as a bioresorbable barrier membrane in combination with a bone substitute, was performed recently by our study group and demonstrated significant improvements in both clinical and radiographic assessments at 1-year follow-up. Nevertheless, there is scarce information in the literature regarding the predictability and long-term stability of autologous growth factors in peri-implantitis management.

It is, therefore, the aim of this study to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or CGF, and moreover, to identify prognostic indicators influencing the long-term reconstructive surgical treatment outcome using a multilevel statistical model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age > 18 years,

• having at least one implant demonstrating two- or three-wall infrabony defect =3 mm, which presented a probing depth of =5 mm with BOP and/or suppuration,

• no implant mobility and no evidence of occlusal overload.

Exclusion Criteria:

• serious systemic diseases, medications or conditions that would contraindicate for periodontal surgery and compromise wound healing,

• a history of taking systemic antibiotic during the past 3 months, and

• placement, and prosthetic loading of implants within the past year.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Device:
• bioresorbable membrane
reconstructive surgical treatment of peri-implant bone defects

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

Aghazadeh A, Persson RG, Renvert S. Impact of bone defect morphology on the outcome of reconstructive treatment of peri-implantitis. Int J Implant Dent. 2020 Jun 17;6(1):33. doi: 10.1186/s40729-020-00219-5. — View Citation

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hämmerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, To — View Citation

Carcuac O, Derks J, Abrahamsson I, Wennström JL, Petzold M, Berglundh T. Surgical treatment of peri-implantitis: 3-year results from a randomized controlled clinical trial. J Clin Periodontol. 2017 Dec;44(12):1294-1303. doi: 10.1111/jcpe.12813. Epub 2017 — View Citation

Isehed C, Svenson B, Lundberg P, Holmlund A. Surgical treatment of peri-implantitis using enamel matrix derivative, an RCT: 3- and 5-year follow-up. J Clin Periodontol. 2018 Jun;45(6):744-753. doi: 10.1111/jcpe.12894. Epub 2018 Apr 26. — View Citation

Khouly I, Pardiñas-López S, Ruff RR, Strauss FJ. Efficacy of growth factors for the treatment of peri-implant diseases: a systematic review and meta-analysis. Clin Oral Investig. 2020 Jul;24(7):2141-2161. doi: 10.1007/s00784-020-03240-5. Epub 2020 May 16. — View Citation

Khoury F, Keeve PL, Ramanauskaite A, Schwarz F, Koo KT, Sculean A, Romanos G. Surgical treatment of peri-implantitis - Consensus report of working group 4. Int Dent J. 2019 Sep;69 Suppl 2:18-22. doi: 10.1111/idj.12505. Review. — View Citation

La Monaca G, Pranno N, Annibali S, Cristalli MP, Polimeni A. Clinical and radiographic outcomes of a surgical reconstructive approach in the treatment of peri-implantitis lesions: A 5-year prospective case series. Clin Oral Implants Res. 2018 Oct;29(10):1 — View Citation

Mercado F, Hamlet S, Ivanovski S. Regenerative surgical therapy for peri-implantitis using deproteinized bovine bone mineral with 10% collagen, enamel matrix derivative and Doxycycline-A prospective 3-year cohort study. Clin Oral Implants Res. 2018 Jun;29 — View Citation

Monje A, Pons R, Roccuzzo A, Salvi GE, Nart J. Reconstructive therapy for the management of peri-implantitis via submerged guided bone regeneration: A prospective case series. Clin Implant Dent Relat Res. 2020 Jun;22(3):342-350. doi: 10.1111/cid.12913. Ep — View Citation

Polymeri A, Anssari-Moin D, van der Horst J, Wismeijer D, Laine ML, Loos BG. Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study. Clin Oral Implants Res. 2020 Nov;31(11):1047-1060. doi: 1 — View Citation

Renvert S, Roos-Jansåker AM, Persson GR. Surgical treatment of peri-implantitis lesions with or without the use of a bone substitute-a randomized clinical trial. J Clin Periodontol. 2018 Oct;45(10):1266-1274. doi: 10.1111/jcpe.12986. Epub 2018 Aug 21. — View Citation

Roccuzzo M, Fierravanti L, Pittoni D, Dalmasso P, Roccuzzo A. Implant survival after surgical treatment of peri-implantitis lesions by means of deproteinized bovine bone mineral with 10% collagen: 10-year results from a prospective study. Clin Oral Implan — View Citation

Roccuzzo M, Layton DM, Roccuzzo A, Heitz-Mayfield LJ. Clinical outcomes of peri-implantitis treatment and supportive care: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:331-350. doi: 10.1111/clr.13287. — View Citation

Tomasi C, Regidor E, Ortiz-Vigón A, Derks J. Efficacy of reconstructive surgical therapy at peri-implantitis-related bone defects. A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:340-356. doi: 10.1111/jcpe.13070. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean vertical radiographic defect depth (VDD)	Radiographic vertical defect depth (VDD) was measured between the first bone-to-implant contact and the reference point at the coronal part of the implant body at both mesial and distal aspects of the implants.	Postoperative 3 years
Secondary	Plaque index	Silness & Löe plaque index (PI) marked with a score from 0 to 3 (0: absence of microbial plaque; 1: thin film of microbial plaque; 2: moderate accumulation with plaque in the sulcus; 3: large amount of plaque in sulcus or pocket along the free gingival margin)	Baseline, postoperative 1 and 3 years
Secondary	Gingival index	Löe & Silness index (GI) marked with a score from 0 to 3. (0: normal gingiva; 1: mild inflammation, 2: moderate inflammation, 3: severe inflammation)	Baseline, postoperative 1 and 3 years
Secondary	Bleeding on probing (percent [%]) (BOP)	BOP was assessed according to presence or absence of bleeding 30 s after gentle probing	Baseline, postoperative 1 and 3 years
Secondary	Probing depth (mm) (PD)	PD was measured as the distance from the mucosal margin to the bottom of the probeable pocket	Baseline, postoperative 1 and 3 years
Secondary	Clinical attachment level (mm) (CAL)	Clinical attachment level (CAL) defined as PD+ mucosal recession.	Baseline, postoperative 1 and 3 years
Secondary	Mucosal recession (mm) (MR)	Mucosal recession (MR) was measured as the distance from the mucosal margin and the implant abutment interface	Baseline, postoperative 1 and 3 years