Reconstructive Surgical Therapy of Peri-implantitis

NCT04769609 | Completed DMC

• 1 other identifier: GUDHKAEK.2021.01/4
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-Implantitis

Keywords

peri-implantitis; biomaterials; surgical treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Plaque index

  Baseline, postoperative 1 and 3 years

• Gingival index

  Baseline, postoperative 1 and 3 years

• Bleeding on probing (percent [%]) (BOP)

  Baseline, postoperative 1 and 3 years

• Probing depth (mm) (PD)

  Baseline, postoperative 1 and 3 years

• Clinical attachment level (mm) (CAL)

  Baseline, postoperative 1 and 3 years

Study Arms (2)

Concentrated growth factor (CGF) group

Reconstructive surgical therapy of peri-implantitis using a bone substitute combined with CGF

Device: bioresorbable membrane

Collagen membrane (CM) group

Reconstructive surgical therapy of peri-implantitis using a bone substitute combined with CM

Device: bioresorbable membrane

Interventions

bioresorbable membrane DEVICE

reconstructive surgical treatment of peri-implant bone defects

Collagen membrane (CM) group; Concentrated growth factor (CGF) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Presence of bleeding on probing (BOP) and/or suppuration (SUP) on gentle probing, and a radiographic marginal bone loss (MBL) ≥ 2 mm based on baseline radiographs taken at the time of prosthesis delivery with increased probing depth (PD) compared to previous examinations.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (15)

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle 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, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  PMID: 29926491 RESULT

• 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(6):583-591. doi: 10.1111/clr.13256. Epub 2018 May 16.

  PMID: 29767434 RESULT

• 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):1025-1037. doi: 10.1111/clr.13369. Epub 2018 Sep 28.

  PMID: 30267445 RESULT

• Tomasi C, Regidor E, Ortiz-Vigon 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.

  PMID: 30667523 RESULT

• 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: 10.1111/clr.13651. Epub 2020 Sep 9.

  PMID: 32803798 RESULT

• Renvert S, Roos-Jansaker 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.

  PMID: 30003583 RESULT

• 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.

  PMID: 30328195 RESULT

• 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.

  PMID: 29574866 RESULT

• 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(Suppl 2):18-22. doi: 10.1111/idj.12505.

  PMID: 31478576 RESULT

• 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 Implants Res. 2020 Aug;31(8):768-776. doi: 10.1111/clr.13628. Epub 2020 Jul 24.

  PMID: 32559322 RESULT

• 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. Epub 2020 May 14.

  PMID: 32410379 RESULT

• 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.

  PMID: 32548733 RESULT

• Carcuac O, Derks J, Abrahamsson I, Wennstrom 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 Nov 10.

  PMID: 28902426 RESULT

• Khouly I, Pardinas-Lopez 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.

  PMID: 32418012 RESULT

• Isler SC, Soysal F, Ceyhanli T, Bakirarar B, Unsal B. Efficacy of concentrated growth factor versus collagen membrane in reconstructive surgical therapy of peri-implantitis: 3-year results of a randomized clinical trial. Clin Oral Investig. 2022 Aug;26(8):5247-5260. doi: 10.1007/s00784-022-04493-y. Epub 2022 May 26.

  PMID: 35618961 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: September 1, 2020
• Primary Completion: February 12, 2021
• Study Completion: February 12, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)