Surgical Access Combined With Systematically Administered Antibiotics in the Treatment of Peri-implantitis

NCT05444218 | Completed

• 2 other identifiers: 40892620.9.0000.55061454_2019
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial evaluates the clinical and microbiological (microbial complexes and changes in the diversity of the submucosal biofilm) effects of MTZ+AMX as adjuncts to anti-infectious surgical treatment plus Er: YAG in the treatment of peri-implantitis.

Conditions

Peri-Implantitis

Keywords

peri-implantitis; open flap debridement; Er:YAG irradiation; metronidazole; amoxicillin; microbiota

Outcome Measures

Primary Outcomes (1)

• Difference between treatment groups for the change in the clinical attachment level (CAL).

  12 months.

Secondary Outcomes (14)

• Percentage of patients (and implants) reaching the following clinical endpoint for treatment: PD< 5mm, absence of BOP and no further bone loss.

  12 months.

• Mean plaque index.

  Baseline, 3, 6 and 12 months.

• Mean gingival index.

  Baseline, 3, 6 and 12 months.

• Percentage of sites with bleeding on probing.

  Baseline, 3, 6 and 12 months.

• Percentage of sites with suppuration.

  Baseline, 3, 6 and 12 months.

Study Arms (2)

Control

PLACEBO COMPARATOR

Open flap debridement + Er: YAG irradiation alone + systemic placebo of metronidazole and amoxicillin thrice a day (TID) for 14 days

Procedure: Open flap debridement; Other: Er: YAG irradiation; Drug: Placebos

Test

EXPERIMENTAL

Open flap debridement + Er: YAG irradiation alone + systemic metronidazole (400mg) and amoxicillin (500mg) thrice a day (TID) for 14 days

Procedure: Open flap debridement; Other: Er: YAG irradiation; Drug: Metronidazole; Drug: Amoxicillin

Interventions

Open flap debridement PROCEDURE

After local anesthesia (2% lidocaine with1:100,000 epinephrine), intrasulcular incisions will be performed to create a horizontal flap extending beyond the adjacent teeth and/or implants. Buccal and lingual full-thickness flaps will be dissected, and granulation tissue will be removed to expose the implant threads and bone defect. The flap will be repositioned in its original position and stabilized with interrupted sutures, which will be removed after 10 days.

Also known as: OFD

Control; Test

Er: YAG irradiation OTHER

An Er:YAG laser (Lite Touch, Light Instruments, Israel) will be used, with an irradiation energy of 20 mJ, frequency of 20 Hz, output power of 0.4 W, and an energy density of 2.76 J/cm2. An 8 mm long sapphire tip will be used in the respective handpiece and not in contact with the titanium surface, with concomitant water spray irrigation, under air 6 and water spray 6, the irradiation angle will be 90 degrees, at a focal distance of 2 mm, with spot size diameter of 1.3 mm

Control; Test

Metronidazole DRUG

Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning after open flap debridement).

Also known as: MTZ

Test

Amoxicillin DRUG

Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning after open flap debridement).

Also known as: AMX

Test

Placebos DRUG

Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (beginning after open flap debridement).

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age;
• in general good health,
• at least one dental implant in function for at least one year with untreated peri-implantitis defined as: presence of bleeding and/or suppuration on gentle probing, probing depths (PD) ≥ 6mm, and bone levels ≥3mm apical of the most coronal portion of the intraosseous part of the implant.

You may not qualify if:

• subjects with ≥6 sites with PD ≥5mm;
• individuals that received periodontal treatment within three months prior to entering the study;
• inability to perform proper supramucosal and supragingival plaque control (e.g., due to improper restoration design or lack of skills);
• poorly adapted implant-supported restoration;
• diabetes;
• pregnancy;
• nursing;
• history of allergies to metronidazole and/or amoxicillin, or any other ingredient of oral care products;
• alcohol or drug abuse;
• any systemic diseases that could affect post-operative healing or that required antibiotic premedication for routine dental therapy;
• long-term use of mouthrinses;
• anti-inflammatory medications;
• any other drug that could interfere with the study outcomes within three months prior to entering the study;
• use of antibiotics within six months prior to entering the study.

Sponsors & Collaborators

• University of Guarulhos: lead
• ITI Foundation: collaborator

Study Sites (1)

University of Guarulhos

Guarulhos, São Paulo, 07023-070, Brazil

Location

Related Publications (16)

• 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 Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.

  PMID: 29926955 BACKGROUND

• Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.

  PMID: 29926957 BACKGROUND

• Dreyer H, Grischke J, Tiede C, Eberhard J, Schweitzer A, Toikkanen SE, Glockner S, Krause G, Stiesch M. Epidemiology and risk factors of peri-implantitis: A systematic review. J Periodontal Res. 2018 Oct;53(5):657-681. doi: 10.1111/jre.12562. Epub 2018 Jun 7.

  PMID: 29882313 BACKGROUND

• Shibli JA, Melo L, Ferrari DS, Figueiredo LC, Faveri M, Feres M. Composition of supra- and subgingival biofilm of subjects with healthy and diseased implants. Clin Oral Implants Res. 2008 Oct;19(10):975-82. doi: 10.1111/j.1600-0501.2008.01566.x.

  PMID: 18828812 BACKGROUND

• Perez-Chaparro PJ, Duarte PM, Shibli JA, Montenegro S, Lacerda Heluy S, Figueiredo LC, Faveri M, Feres M. The Current Weight of Evidence of the Microbiologic Profile Associated With Peri-Implantitis: A Systematic Review. J Periodontol. 2016 Nov;87(11):1295-1304. doi: 10.1902/jop.2016.160184. Epub 2016 Jul 15.

  PMID: 27420109 BACKGROUND

• Faggion CM Jr, Listl S, Fruhauf N, Chang HJ, Tu YK. A systematic review and Bayesian network meta-analysis of randomized clinical trials on non-surgical treatments for peri-implantitis. J Clin Periodontol. 2014 Oct;41(10):1015-25. doi: 10.1111/jcpe.12292. Epub 2014 Aug 11.

  PMID: 25039292 RESULT

• Swider K, Dominiak M, Grzech-Lesniak K, Matys J. Effect of Different Laser Wavelengths on Periodontopathogens in Peri-Implantitis: A Review of In Vivo Studies. Microorganisms. 2019 Jun 29;7(7):189. doi: 10.3390/microorganisms7070189.

  PMID: 31261945 RESULT

• Aoki A, Mizutani K, Schwarz F, Sculean A, Yukna RA, Takasaki AA, Romanos GE, Taniguchi Y, Sasaki KM, Zeredo JL, Koshy G, Coluzzi DJ, White JM, Abiko Y, Ishikawa I, Izumi Y. Periodontal and peri-implant wound healing following laser therapy. Periodontol 2000. 2015 Jun;68(1):217-69. doi: 10.1111/prd.12080.

  PMID: 25867988 RESULT

• Shibli JA. Is Laser the Best Choice for the Treatment of Peri-Implantitis? Photomed Laser Surg. 2018 Nov;36(11):569-570. doi: 10.1089/pho.2018.4521. No abstract available.

  PMID: 30422756 RESULT

• Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol 2000. 2015 Feb;67(1):131-86. doi: 10.1111/prd.12075.

  PMID: 25494600 RESULT

• Feres M, Retamal-Valdes B, Fermiano D, Faveri M, Figueiredo LC, Mayer MPA, Lee JJ, Bittinger K, Teles F. Microbiome changes in young periodontitis patients treated with adjunctive metronidazole and amoxicillin. J Periodontol. 2021 Apr;92(4):467-478. doi: 10.1002/JPER.20-0128. Epub 2020 Oct 12.

  PMID: 32844406 RESULT

• Teughels W, Feres M, Oud V, Martin C, Matesanz P, Herrera D. Adjunctive effect of systemic antimicrobials in periodontitis therapy: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:257-281. doi: 10.1111/jcpe.13264.

  PMID: 31994207 RESULT

• Shibli JA, Ferrari DS, Siroma RS, Figueiredo LC, Faveri M, Feres M. Microbiological and clinical effects of adjunctive systemic metronidazole and amoxicillin in the non-surgical treatment of peri-implantitis: 1 year follow-up. Braz Oral Res. 2019 Sep 30;33(suppl 1):e080. doi: 10.1590/1807-3107bor-2019.vol33.0080. eCollection 2019.

  PMID: 31576959 RESULT

• Tamashiro NS, Duarte PM, Miranda TS, Maciel SS, Figueiredo LC, Faveri M, Feres M. Amoxicillin Plus Metronidazole Therapy for Patients with Periodontitis and Type 2 Diabetes: A 2-year Randomized Controlled Trial. J Dent Res. 2016 Jul;95(7):829-36. doi: 10.1177/0022034516639274. Epub 2016 Mar 24.

  PMID: 27013640 RESULT

• Borges I, Faveri M, Figueiredo LC, Duarte PM, Retamal-Valdes B, Montenegro SCL, Feres M. Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial. J Clin Periodontol. 2017 Aug;44(8):822-832. doi: 10.1111/jcpe.12721. Epub 2017 Jul 26.

  PMID: 28303587 RESULT

• Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.

  PMID: 26285807 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Metronidazole; Amoxicillin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jamil A Shibli, Professor

  University of Guarulhos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: May 1, 2021
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)