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Peri-ImplantitisNCT05444218

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

A study testing Open flap debridement, Er: YAG irradiation and Metronidazole in people with Peri-Implantitis, run by University of Guarulhos at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Peri-Implantitis
What is being tested?
Open flap debridement, Er: YAG irradiation and Metronidazole
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
89 participants
Where
1 siteBrazil
Study dates
1 May 2021to 16 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of Guarulhos

    Guarulhos, São Paulo, 07023-070

Other trials in Brazil

About this study

Official title: Clinical and Microbiological Effects of Surgical Access Combined With Systematically Administered Antibiotics in the Treatment of Peri-implantitis: 1-year Randomized Double-blinded Controlled Clinical Trial

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.

Read the detailed description

Peri-implantitis is a pathological condition characterized by inflammation of peri-implant connective tissues and progressive peri-implant bone. Recently, the therapeutic protocol using non-surgical debridement associated with the combination of systemic metronidazole (MTZ) and amoxicillin (AMX) has not been shown to be effective in controlling the disease. These unfavorable results may have occurred due to the limitation in the change of the submucosal microbiological profile due to mechanical difficulties in the decontamination of the implant threads. Therefore, this randomized clinical trial (RCT) aimed to evaluate 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. Ninety-four subjects with untreated peri-implantitis are being included and will be randomly assigned to receive (i) open flap debridement plus Er:YAG irradiation alone (control), or (ii) with adjunctive systemically administered MTZ (400 mg) + AMX (500 mg) thrice a day (TID) for 14 days (test). Subjects will be monitored up to 12 months post-treatment. Submucosal biofilm samples from the deepest site of each implant with peri-implantitis will be collected in duplicate per patient: at baseline and at 3, 6 and 12 months post-therapy and analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species, and at baseline, 3 and 12 months post-treatment for 16S rRNA sequencing (Ion Torrent PGM System). The primary outcome variable of this trial will be the difference between treatment groups for the change in CAL from baseline to 12 months. The significance of differences in each group (over the course of the study) will be sought using the Student's-t test; and among groups (at each time point) using either ANOVA /ANCOVA or Kruskal Wallis tests and post-hoc analyses, depending on normality of the data. Fisher's exact test will be used to compare differences in the frequency of gender. Statistical significance will be set at 5%.

Being tested
Open flap debridement, Er: YAG irradiation, Metronidazole, Amoxicillin, Placebos
Keywords
peri-implantitis, open flap debridement, Er:YAG irradiation, metronidazole, amoxicillin, microbiota
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open flap debridementProcedure or surgery

    Also called OFD

    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.

  • Er: YAG irradiationOther

    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

  • MetronidazoleDrug

    Also called MTZ

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

  • AmoxicillinDrug

    Also called AMX

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

  • PlacebosDrug

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

Study groups in NCT05444218
Study groupRoleWhat they receive
ControlPlacebo comparatorOpen flap debridement + Er: YAG irradiation alone + systemic placebo of metronidazole and amoxicillin thrice a day (TID) for 14 days
Receives: Procedure: Open flap debridement; Other: Er: YAG irradiation; Drug: Placebos
TestExperimentalOpen flap debridement + Er: YAG irradiation alone + systemic metronidazole (400mg) and amoxicillin (500mg) thrice a day (TID) for 14 days
Receives: Procedure: Open flap debridement; Other: Er: YAG irradiation; Drug: Metronidazole; Drug: Amoxicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months.

Secondary outcomes (14)

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

    Measured: 12 months.

  2. Mean plaque index.

    Measured: Baseline, 3, 6 and 12 months.

  3. Mean gingival index.

    Measured: Baseline, 3, 6 and 12 months.

  4. Percentage of sites with bleeding on probing.

    Measured: Baseline, 3, 6 and 12 months.

  5. Percentage of sites with suppuration.

    Measured: Baseline, 3, 6 and 12 months.

  6. Probing depth.

    Measured: Baseline, 3, 6 and 12 months.

  7. Occurrence of headache obtained through a questionnaire of adverse effects.

    Measured: 14 days after taking antibiotic.

  8. Occurrence of vomiting obtained through a questionnaire of adverse effects.

    Measured: 14 days after taking antibiotic.

  9. Occurrence of diarrhea obtained through a questionnaire of adverse effects.

    Measured: 14 days after taking antibiotic.

  10. Occurrence of metallic taste obtained through a questionnaire of adverse effects.

    Measured: 14 days after taking antibiotic.

  11. Occurrence of nausea obtained through a questionnaire of adverse effects.

    Measured: 14 days after taking antibiotic.

  12. Occurrence of irritability obtained through a questionnaire of adverse effects.

    Measured: 14 days after taking antibiotic.

  13. Proportions of periodontal pathogenic bacterial species.

    Measured: Baseline, 3, 6 and 12 months.

  14. Counts of periodontal pathogenic bacterial species.

    Measured: Baseline, 3, 6 and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start1 May 2021
  3. Primary completion16 Jul 2024
  4. Study completion16 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444218
Sponsor's protocol ID
40892620.9.0000.5506
Other IDs
1454_2019
Status last verified
Jul 2024
First submitted
29 Jun 2022
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29926955

  • 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.

    PubMed 29926957

  • 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.

    PubMed 29882313

  • 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.

    PubMed 18828812

  • 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.

    PubMed 27420109

  • 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.

    PubMed 25039292

  • 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.

    PubMed 31261945

  • 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.

    PubMed 25867988

  • 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.

    PubMed 30422756

  • 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.

    PubMed 25494600

  • 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.

    PubMed 32844406

  • 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.

    PubMed 31994207

  • 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.

    PubMed 31576959

  • 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.

    PubMed 27013640

  • 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.

    PubMed 28303587

Questions about this trial

What is this clinical trial studying?

A study testing Open flap debridement, Er: YAG irradiation and Metronidazole in people with Peri-Implantitis, run by University of Guarulhos at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference between treatment groups for the change in the clinical attachment level (CAL). (time frame: 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444218, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.

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