Peri-ImplantitisNCT05539755
Outcome Indicators of Non-surgical Therapy of Peri-implantitis
A study testing Non surgical debridement of peri-implantitis in people with Peri-Implantitis and Infections, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Objectives: To identify patient and implant indicators influencing the non-surgical therapeutic outcomes of peri-implantitis at 6-months follow-up. Material and methods: This prospective cohort study included patients with at least one implant diagnosed with peri-implantitis according to the 2017 World Workshop. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis, Infections
- What is being tested?
- Non surgical debridement of peri-implantitis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 12 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over 18 years old
- At least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).
Who cannot join
- Previous surgical therapy of peri-implantitis
- Allergy to metronidazole
- Clinical implant mobility
- Pregnancy or lactating females
- Previous non-surgical treatment (i.e., submucosal debridement) of the affected implants at least 12 months before
- Use of systemic antibiotics during the previous 3 months as well as use of systemic antibiotics for endocarditis prophylaxis,
- Systemic diseases, medications, or conditions that may compromise wound healing and influence the outcome of the therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome Indicators of Non-surgical Therapy of Peri-implantitis: a 6-months
Objectives: To identify patient and implant indicators influencing the non-surgical therapeutic outcomes of peri-implantitis at 6-months follow-up.
Material and methods: This prospective cohort study included patients with at least one implant diagnosed with peri-implantitis according to the 2017 World Workshop. Non-surgical therapy consisted in a mechanical debridement of the peri-implant pockets combined with the metronidazole 500 mg every 8 hours during 7 days. At baseline and at 6 months, clinical and radiographic variables were collected to calculate the success of the therapy. The influence of patient and implant/prosthetic variables on disease resolution were assessed trough simple and multiple logistic regression analysis at patient and implant level using generalized estimation equations models.
- Conditions
- Peri-Implantitis, Infections
- Being tested
- Non surgical debridement of peri-implantitis
- Medical subject headings
- Peri-Implantitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical debridement of peri-implantitisProcedure or surgery
The procedure was standardized as follows: the implants' prosthesis was checked for its cleansability, and retrieved when possible. Then, the prosthesis was modified following a previously described elsewhere (de Tapia et al., 2019). After local anaesthesia (articaine 4% and adrenaline 1:100,000), the implant surfaces were cleaned with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the steel alloy H3 dental ultrasonic scaler tip (H3, Satelec Acteon; Olliergues, France), curettage (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) of the bone defect was performed, and glycine air powder applied submucosally (Air-flow® powder subgingival PERIO, EMS; Nyon, France) with an air-flow piezon device (Air-flow master piezon®, EMS, Nyon; France).
Oral hygiene instructions were given and metronidazole 500 mg every 8 h for 7 days was prescribed. Patients were scheduled at 3 months for supragingival plaque control and supragingival debridement, if needed.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical therapy of peri-implantitis | Experimental | Subjects over 18 years old were consecutively included in the study if they present at least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018). Receives: Procedure: Non surgical debridement of peri-implantitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease resolution
Probing pocket depth reduction to 5 mm without bleeding on probing (BoP) or <5 mm irrespective to BoP in all implant sites together with lack of progression of peri-implant bone loss
Measured: 6 months
Secondary outcomes (6)
Changes in PPD
Measured in mm from the mucosal margin to the base of the peri-implant pocket in 6 sites per tooth
Measured: From baseline to 6 months
Changes in Bleeding on probing (BoP)
Assessed dichotomously (yes/no) in six sites per tooth
Measured: From baseline to 6 months
Changes in Suppuration on probing (BoP)
Assessed dichotomously (yes/no) in six sites per tooth
Measured: From baseline to 6 months
Changes in soft tissue margin
Measured in mm from the mucosal margin to the most apical portion of the crown in 6 sites per tooth
Measured: From baseline to 6 months
Changes
Measured in mm from the mucosal margin to mucogingival line in 6 sites per tooth
Measured: From baseline to 6 months
Plaque index (PI)
Calculated by assigning a binary score to each surface (1 for plaque present, 0 for absent).
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2022
- Study completion12 Jul 2022
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javi Vilarrasa, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539755
- Sponsor's protocol ID
- PER-ECL-2020-06
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Indicators of Non-surgical Therapy of Peri-implantitis: a 6-months
- ClinicalTrials.gov ID
- NCT05539755
- Acronym / sponsor ID
- PER-ECL-2020-06
- Conditions
- Peri-Implantitis, Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 14 Sep 2022 (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.
Objectives: To identify patient and implant indicators influencing the non-surgical therapeutic outcomes of peri-implantitis at 6-months follow-up.
Material and methods: This prospective cohort study included patients with at least one implant diagnosed with peri-implantitis according to the 2017 World Workshop. Non-surgical therapy consisted in a mechanical debridement of the peri-implant pockets combined with the metronidazole 500 mg every 8 hours during 7 days. At baseline and at 6 months, clinical and radiographic variables were collected to calculate the success of the therapy. The influence of patient and implant/prosthetic variables on disease resolution were assessed trough simple and multiple logistic regression analysis at patient and implant level using generalized estimation equations models.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-surgical therapy of peri-implantitis | Experimental | Procedure: Non surgical debridement of peri-implantitisSubjects over 18 years old were consecutively included in the study if they present at least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects over 18 years old
- At least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).
Key exclusion criteria (7 listed)
- Previous surgical therapy of peri-implantitis
- Allergy to metronidazole
- Clinical implant mobility
- Pregnancy or lactating females
- Previous non-surgical treatment (i.e., submucosal debridement) of the affected implants at least 12 months before
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 |
|---|---|---|
| Non surgical debridement of peri-implantitisThe procedure was standardized as follows: the implants' prosthesis was checked for its cleansability, and retrieved when possible. Then, the prosthesis was modified following a previously described elsewhere (de Tapia et al., 2019). After local anaesthesia (articaine 4% and adrenaline 1:100,000), the implant surfaces were cleaned with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the steel alloy H3 dental ultrasonic scaler tip (H3, Satelec Acteon; Olliergues, France), curettage (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) of the bone defect was performed, and glycine air powder applied submucosally (Air-flow® powder subgingival PERIO, EMS; Nyon, France) with an air-flow piezon device (Air-flow master piezon®, EMS, Nyon; France). Oral hygiene instructions were given and metronidazole 500 mg every 8 h for 7 days was prescribed. Patients were scheduled at 3 months for supragingival plaque control and supragingival debridement, if needed. | Procedure or surgery | Non-surgical therapy of peri-implantitis |
Primary outcome
Disease resolution
Time frame: 6 months
Probing pocket depth reduction to 5 mm without bleeding on probing (BoP) or <5 mm irrespective to BoP in all implant sites together with lack of progression of peri-implant bone loss
6 secondary outcomes
Changes in PPD
Time frame: From baseline to 6 months
Changes in Bleeding on probing (BoP)
Time frame: From baseline to 6 months
Changes in Suppuration on probing (BoP)
Time frame: From baseline to 6 months
Changes in soft tissue margin
Time frame: From baseline to 6 months
Changes
Time frame: From baseline to 6 months
Plaque index (PI)
Time frame: From baseline to 6 months
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 14 Sep 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical debridement of peri-implantitis in people with Peri-Implantitis and Infections, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 2 inclusion and 7 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 14 Sep 2022. 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 Spain. 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. 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?
Disease resolution (time frame: 6 months). 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 14 Sep 2022.