Treatment of failing dental implants using deep cleaning with or without antibiotics
| ISRCTN | ISRCTN10896644 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10896644 |
| Secondary identifying numbers | NL 39371.018.12 |
- Submission date
- 08/11/2021
- Registration date
- 30/11/2021
- Last edited
- 18/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Peri-implantitis is a destructive inflammatory process affecting the soft and hard tissues surrounding dental implants. Existing treatments are unpredictable at arresting the disease and current evidence does not support a gold-standard treatment. The use of systemic antibiotics, especially metronidazole or the combination of amoxicillin and metronidazole, in the non-surgical treatment of gum disease (periodontitis) has been widely investigated and in some cases has shown improvement. Therefore, antimicrobials have also been proposed for peri-implantitis treatment and are widely used by clinicians from all over the world, although the scientific evidence for their use is still inconclusive. The aim of this study is to evaluate the results of the use of amoxicillin and metronidazole in conjunction with non-surgical treatment, in comparison to non-surgical treatment alone.
Who can participate?
Patients aged 18 years and over with peri-implantitis
What does the study involve?
The patients are randomly assigned into one of the following treatments: submucosal debridement of the diseased implant (removal of dead or damaged tissue) with systemic antibiotics (amoxicillin and metronidazole three times a day for 7 days) and chlorhexidine mouthwash (two times a day for 4 weeks), or submucosal debridement with chlorhexidine mouthwash (two times a day for 4 weeks).
Possible risks and benefits of participating?
The burden and risks in this study are not different when compared to regular clinical treatment. The antibiotics used in this study are regularly used in dental practices and may cause side effects (e.g. upset stomach, diarrhea, yeast vaginal infections etc). Participants in both groups can expect the benefit of reduced peri-implant infection which can lead to better maintenance of the peri-implant tissue. This may result in less need for surgical treatments of peri-implant lesions and less implant failure in the future.
Where is the study run from?
Academic Centre for Dentistry Amsterdam (ACTA) (Netherlands)
When is the study starting and how long is it expected to run for?
September 2011 to March 2018
Who is funding the study
Academic Centre for Dentistry Amsterdam (ACTA) (Netherlands)
Who is the main contact?
Dr Angeliki Polymeri
a.polymeri@acta.nl
Contact information
Scientific
ACTA, Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
 ORCID ID |
0000-0002-5583-0365 |
|---|---|
| Phone | +31 (0)20 59 80151 |
| a.polymeri@acta.nl |
Study information
| Study design | Randomized controlled single-blinded clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 40643_PIS_31Oct12.pdf |
| Scientific title | Non-surgical peri-implantitis treatment with or without systemic antibiotics: a randomized controlled clinical trial |
| Study hypothesis | The null hypothesis is that no differences exist between treatment approaches (non-surgical treatment alone vs non-surgical treatment with amoxicillin and metronidazole). |
| Ethics approval(s) | Approved 30/10/2012, the ethical committee of the VU Medical Centre, Amsterdam (Medisch Ethische Toetsingscommissie, Academic Medical Center, University of Amsterdam. Meibergdreef 9 Postbus 22660, 1100 DD, Amsterdam, Netherlands; +31 (0)205667389; mecamc@amsterdamumc.nl), ref: NL 39371.018.12 |
| Condition | Peri-implantitis in patients with dental implants |
| Intervention | The study participants are recruited from the Department of Oral Implantology and Prosthodontics or the Department of Periodontology at the Academic Centre for Dentistry Amsterdam (ACTA). Using a block randomization design, patients who meet the inclusion criteria are assigned into one of the following treatment protocols: non-surgical treatment (NST) with amoxicillin 375 mg and metronidazole 250 mg (3 times a day for 7 days) and chlorhexidine mouthwash (0.12%, 2 times a day for 4 weeks, experimental group), or NST with chlorhexidine mouthwash (0.12%, 2 times a day for 4 weeks, control group). |
| Intervention type | Mixed |
| Primary outcome measure | Peri-implant probing depth (PIPD) measured to the closest mm from the mucosal margin to the base of the pocket using a periodontal probe (PCP-UNC 15; Hu-Friedy, Chicago, IL, USA). Measured at baseline and at 12 weeks. |
| Secondary outcome measures | Measured at baseline and 12 weeks: 1. Clinical attachment level (CAL) measured in mm using a stent with a fixed reference line with a periodontal probe (PCP-UNC 15; Hu-Friedy, Chicago, IL, USA) 2. Bleeding on probing (BoP), presence or absence, measured with a periodontal probe (PCP-UNC 15; Hu-Friedy, Chicago, IL, USA) 3. Suppuration on probing (SoP) presence or absence, measured with a periodontal probe (PCP-UNC 15; Hu-Friedy, Chicago, IL, USA) 4. Plaque Index (PI): the percentage of sites with plaque evaluated with visual inspection |
| Overall study start date | 08/09/2011 |
| Overall study end date | 22/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | At least 32 patients |
| Total final enrolment | 37 |
| Participant inclusion criteria | 1. Systemically healthy, adult patients (≥18 years old) 2. At least one failing dental implant (peri-implantitis) 3. The implant is in function for more than 1 year 4. Presents PIPD ≥5 mm, bleeding and/or suppuration on probing (BoP/SoP) 5. Marginal bone loss ≥3 mm detected radiographically |
| Participant exclusion criteria | 1. Use of systemic antibiotics within the past 3 months 2. Any chronic medical disease or condition 3. Known allergy to penicillin or metronidazole 4. Use of anti-inflammatory prescription medications within the past 4 weeks 5. Pregnancy or lactation 6. Presence of implant mobility |
| Recruitment start date | 19/12/2012 |
| Recruitment end date | 23/03/2017 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1081 LA
Netherlands
Sponsor information
University/education
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
| Phone | +31 (0)20 598 0380 |
|---|---|
| paro@acta.nl | |
| Website | http://www.acta.nl/en/ |
"ROR" |
https://ror.org/04x5wnb75 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 21/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study is planned for publication in Clinical Oral Implants Research (COIR). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Angeliki Polymeri (a.polymeri@acta.nl) for 2 years after the publication of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 31/10/2012 | 29/11/2021 | No | Yes | |
| Protocol file | 29/11/2021 | No | No | ||
| Results article | 15/03/2022 | 18/07/2022 | Yes | No |
Additional files
Editorial Notes
18/07/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
29/11/2021: Trial's existence confirmed by the ethical committee of the VU Medical Centre.
