Peri-implantitisPhase 4NCT04149327
Systemic Amoxicillin Plus Metronidazole in Peri-implantitis Treatment
A Phase 4 study testing amoxicillin 500 mg + metronidazole 500 mg and non-surgical periodontal and peri-implant treatment in people with Peri-implantitis and Periodontal Diseases, run by University Medical Center Groningen.
Trial summary
The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis, Periodontal Diseases
- What is being tested?
- amoxicillin 500 mg + metronidazole 500 mg and non-surgical periodontal and peri-implant treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2012to Dec 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is ≥ 18 years of age;
- The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone ≥ 2 mm as compared to the shoulder of the implant (the level at which the bone is normally located immediately after implant placement), in combination with bleeding and/or suppuration on probing and a peri-implant probing depth ≥ 5 mm;
- The implants have been in function for at least two years;
- The patient is capable of understanding and giving informed consent.
Who cannot join
- Medical and general contraindications for the surgical procedures;
- A history of local radiotherapy to the head and neck region;
- Pregnancy and lactation;
- Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol)
- Mononucleosis infectiosa
- Organic neurological disorders
Show all 18Show fewer
- Use of antibiotics during the last 3 months;
- Known allergy to amoxicillin, metronidazole or chlorhexidine;
- Long-term use of anti-inflammatory drugs;
- Full edentulism (no remaining teeth, only implants)
- Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
- Implants placed in areas augmented with autogenous bone from the crista iliac region;
- Implants placed in skin grafted areas;
- Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
- Implant mobility;
- Implants at which no position can be identified where proper probing measurements can be performed;
- Previous surgical treatment of the peri-implantitis lesions;
- Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curettage)
About this study
Official title: Systemic Antibiotic Therapy (Amoxicillin Plus Metronidazole) as an Adjunct to Initial Non-surgical Treatment of Peri-implantitis; a Single Blind Randomized Controlled Study
The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. The secondary objective is to assess the microbiological effectiveness of this peri-implantitis treatment approach.
The present study is a single-blind, randomized controlled clinical trial. Adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of periimplantitis will be included in this study.
Read more
Patients with implants affected by peri-implantitis will receive initial periodontal treatment existing of oral hygiene instructions and mechanical cleansing of both implants and remaining dentition. Immediately after initial periodontal therapy patients will be instructed to rinse their mouth with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds for 2 weeks. Additionally patients will receive a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days or no recipe.
The main study parameter is the mean peri-implant bleeding score.
- Conditions
- Peri-implantitis, Periodontal Diseases
- Being tested
- amoxicillin 500 mg + metronidazole 500 mg, non-surgical periodontal and peri-implant treatment
- Medical subject headings
- Peri-Implantitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin 500 mg + metronidazole 500 mgDrug
500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for 7 days
non-surgical periodontal and peri-implant treatmentProcedure or surgery
Patients are instructed on how to perform proper oral hygiene measures using an electric toothbrush, interdental brushes (to be used in combination with Corsodyl® gel) and floss (Oral-B® superfloss or Meridol® floss, at implants only).
Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics group | Experimental | Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days plus a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks. Receives: Drug: amoxicillin 500 mg + metronidazole 500 mg; Procedure: non-surgical periodontal and peri-implant treatment |
| Control group | Active comparator | Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks. Receives: Procedure: non-surgical periodontal and peri-implant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline mean peri-implant bleeding score at 3 months
in percentages ranging from 0 (no change) to 100 (improvement)
Measured: 3 months after therapy
Secondary outcomes (11)
change from baseline full-mouth periodontal bleeding score at 3 months
in percentages ranging from 0 (no change) to 100 (improvement)
Measured: 3 months after therapy
change from baseline mean peri-implant and baseline full-mouth periodontal suppuration on probing score at 3 months
in percentages ranging from 0 (no change) to 100 (improvement)
Measured: 3 months after therapy
change from baseline mean peri-implant and full-mouth periodontal probing pocket depth at 3 months
in millimeters ranging from 0 (no change) to high (improvement)
Measured: 3 months after therapy
change from baseline mean peri-implant and full-mouth periodontal plaque score at 3 months
in percentages ranging from 0 (no change) to 100 (improvement)
Measured: 3 months after therapy
change from baseline marginal soft tissue level at 3 months
in millimeters ranging from 0 (no change) to high (worsening)
Measured: 3 months after therapy
change from baseline radiographic marginal peri-implant bone level at 3 months
in millimeters ranging from 0 (no change) to high (worsening)
Measured: 3 months after therapy
change from baseline in detection frequency of 7 periodontal pathogens potentially residing in the peri-implant and periodontal area at 3 months
Measured: 3 months after therapy
number of patients in need for additional surgery at teeth and implants
Measured: 3 months after therapy
number of patients with implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection
Measured: 3 months after therapy
number of patients with tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection
Measured: 3 months after therapy
number of patients with adverse events related to the treatment
Measured: 3 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Aug 2012
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149327
- Sponsor's protocol ID
- NL41441.042.12
- Status last verified
- Apr 2024
- First submitted
- 26 Oct 2019
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Antibiotic Therapy (Amoxicillin Plus Metronidazole) as an Adjunct to Initial Non-surgical Treatment of Peri-implantitis; a Single Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04149327
- Acronym / sponsor ID
- NL41441.042.12
- Conditions
- Peri-implantitis, Periodontal Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. The secondary objective is to assess the microbiological effectiveness of this peri-implantitis treatment approach.
The present study is a single-blind, randomized controlled clinical trial. Adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of periimplantitis will be included in this study.
Patients with implants affected by peri-implantitis will receive initial periodontal treatment existing of oral hygiene instructions and mechanical cleansing of both implants and remaining dentition. Immediately after initial periodontal therapy patients will be instructed to rinse their mouth with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds for 2 weeks. Additionally patients will receive a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days or no recipe.
The main study parameter is the mean peri-implant bleeding score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics group | Experimental | Drug: amoxicillin 500 mg + metronidazole 500 mg, Procedure: non-surgical periodontal and peri-implant treatmentPatients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days plus a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks. |
| Control group | Active comparator | Procedure: non-surgical periodontal and peri-implant treatmentPatients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is ≥ 18 years of age;
- The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone ≥ 2 mm as compared to the shoulder of the implant (the level at which the bone is normally located immediately after implant placement), in combination with bleeding and/or suppuration on probing and a peri-implant probing depth ≥ 5 mm;
- The implants have been in function for at least two years;
- The patient is capable of understanding and giving informed consent.
Key exclusion criteria (18 listed)
- Medical and general contraindications for the surgical procedures;
- A history of local radiotherapy to the head and neck region;
- Pregnancy and lactation;
- Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol)
- Mononucleosis infectiosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amoxicillin 500 mg + metronidazole 500 mg500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for 7 days | Drug | Antibiotics group |
| non-surgical periodontal and peri-implant treatmentPatients are instructed on how to perform proper oral hygiene measures using an electric toothbrush, interdental brushes (to be used in combination with Corsodyl® gel) and floss (Oral-B® superfloss or Meridol® floss, at implants only). Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned. | Procedure or surgery | Antibiotics group, Control group |
Primary outcome
change from baseline mean peri-implant bleeding score at 3 months
Time frame: 3 months after therapy
in percentages ranging from 0 (no change) to 100 (improvement)
11 secondary outcomes
change from baseline full-mouth periodontal bleeding score at 3 months
Time frame: 3 months after therapy
change from baseline mean peri-implant and baseline full-mouth periodontal suppuration on probing score at 3 months
Time frame: 3 months after therapy
change from baseline mean peri-implant and full-mouth periodontal probing pocket depth at 3 months
Time frame: 3 months after therapy
change from baseline mean peri-implant and full-mouth periodontal plaque score at 3 months
Time frame: 3 months after therapy
change from baseline marginal soft tissue level at 3 months
Time frame: 3 months after therapy
change from baseline radiographic marginal peri-implant bone level at 3 months
Time frame: 3 months after therapy
change from baseline in detection frequency of 7 periodontal pathogens potentially residing in the peri-implant and periodontal area at 3 months
Time frame: 3 months after therapy
number of patients in need for additional surgery at teeth and implants
Time frame: 3 months after therapy
number of patients with implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection
Time frame: 3 months after therapy
number of patients with tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection
Time frame: 3 months after therapy
number of patients with adverse events related to the treatment
Time frame: 3 months after therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amoxicillin 500 mg + metronidazole 500 mg and non-surgical periodontal and peri-implant treatment in people with Peri-implantitis and Periodontal Diseases, run by University Medical Center Groningen.
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 4 inclusion and 18 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change from baseline mean peri-implant bleeding score at 3 months (time frame: 3 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.