Peri-implant MucositisNCT05711576
Non-surgical Mechanical Debridement With or Without Full-mouth Disinfection in the Treatment of Peri-implant Mucositis
A study testing Full mouth disinfection in people with Peri-implant Mucositis, run by University of Catania at 1 site in Italy.
Trial summary
To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without full-mouth disinfection approach (FMD). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Full mouth disinfection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 28 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years old;
- implants with smooth necks supporting cemented or screw-retained single-unit crowns with at least one BOP-positive site (Berglundh et al., 2018),
- implants placed in both maxilla and mandible
- patients with gingivitis or treated periodontitis with the absence of residual PD ≥5 mm
- presence at least of 2 mm of keratinized mucosa (KT) at implant sites
Who cannot join
- presence of systemic diseases;
- pregnancy or lactating;
- use of inflammatory drugs or antibiotics within 3 months prior to study recruitment;
- implants with modified (i.e., micro-rough) necks;
- interproximal open contacts between implant restoration and adjacent teeth;
- peri-implantitis (Berglundh et al., 2018)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Non-surgical Mechanical Debridement With or Without Full-mouth Disinfection in the Treatment of Peri-implant Mucositis. A Randomized Placebo-controlled Clinical Trial
To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without full-mouth disinfection approach (FMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI and full-mouth disinfection (FMD) with respect to NSPI and placebo in the treatment of PM at 6 months follow-up. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.
Read the detailed description
Fifty-six patients with 85 Implants affected by PM were randomly assigned to test (NSMD+FMD) or control procedures (NSMD + placebo). At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) were assessed. Furthermore, the proportions of Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola were also recorded. The BOP reduction was set as a primary outcome and the patient was considered statistical unit. Data were analysed to assess BOP reduction at a 6-month follow-up and to identify significant predictors of implant-site BOP through mixed generalized linear regression.
- Conditions
- Peri-implant Mucositis
- Being tested
- Placebo mouthwash, Full mouth disinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo mouthwashOther
Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo mouthwash
Full mouth disinfectionOther
Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of full mouth disinfection (FMD) approach
| Study group | Role | What they receive |
|---|---|---|
| non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash | Placebo comparator | Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash Receives: Other: Placebo mouthwash |
| non-surgical sub-marginal peri-implant instrumentation (NSPI) with FMD | Active comparator | Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with full-mouth disinfection approach (FMD). Receives: Other: Full mouth disinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BOP) changes
The number of implants presenting with complete absence of BOP or implants with limited extent of BOP (≤1 spot/implant-the presence of a single spot)
Measured: 6-months
Secondary outcomes (5)
Probing pocket depth (PPD) changes
Changes in PPD
Measured: 6-months
Full mouth plaque score (FMPS) % changes
Changes in FMPS%
Measured: 6-months
Full mouth bleeding score (FMBS) % changes
Changes in FMBS%
Measured: 6-months
Plaque at implant sites according to modified gingival index (mGI) changes score
Changes in mGI 0-4 score
Measured: 6-months
Plaque at implant sites according to modified plaque index (mPlI) changes score
Changes in mPlI 0-4 score
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Mar 2023
- Primary completion20 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) were assessed.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, Università degli Studi di Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711576
- Sponsor's protocol ID
- 150/2679/2022/PO
- Status last verified
- Sep 2024
- First submitted
- 26 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results and clinical protocol
Publications
Isola G, Polizzi A, Santagati M, Alibrandi A, Iorio-Siciliano V, Ramaglia L. Effect of Nonsurgical Mechanical Debridement With or Without Chlorhexidine Formulations in the Treatment of Peri-Implant Mucositis. A Randomized Placebo-Controlled Clinical Trial. Clin Oral Implants Res. 2025 May;36(5):566-577. doi: 10.1111/clr.14405. Epub 2025 Jan 25.
PubMed 39865359
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-surgical Mechanical Debridement With or Without Full-mouth Disinfection in the Treatment of Peri-implant Mucositis. A Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05711576
- Acronym / sponsor ID
- 150/2679/2022/PO
- Conditions
- Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 3 Feb 2023 (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.
To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without full-mouth disinfection approach (FMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI and full-mouth disinfection (FMD) with respect to NSPI and placebo in the treatment of PM at 6 months follow-up. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.
Detailed description
Fifty-six patients with 85 Implants affected by PM were randomly assigned to test (NSMD+FMD) or control procedures (NSMD + placebo). At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) were assessed. Furthermore, the proportions of Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola were also recorded. The BOP reduction was set as a primary outcome and the patient was considered statistical unit. Data were analysed to assess BOP reduction at a 6-month follow-up and to identify significant predictors of implant-site BOP through mixed generalized linear regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) were assessed.
| Arm | Type | Receives |
|---|---|---|
| non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash | Placebo comparator | Other: Placebo mouthwashPatients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash |
| non-surgical sub-marginal peri-implant instrumentation (NSPI) with FMD | Active comparator | Other: Full mouth disinfectionPatients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with full-mouth disinfection approach (FMD). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥18 years old;
- implants with smooth necks supporting cemented or screw-retained single-unit crowns with at least one BOP-positive site (Berglundh et al., 2018),
- implants placed in both maxilla and mandible
- patients with gingivitis or treated periodontitis with the absence of residual PD ≥5 mm
- presence at least of 2 mm of keratinized mucosa (KT) at implant sites
Key exclusion criteria (6 listed)
- presence of systemic diseases;
- pregnancy or lactating;
- use of inflammatory drugs or antibiotics within 3 months prior to study recruitment;
- implants with modified (i.e., micro-rough) necks;
- interproximal open contacts between implant restoration and adjacent teeth;
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 |
|---|---|---|
| Placebo mouthwashPatients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo mouthwash | Other | non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash |
| Full mouth disinfectionPatients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of full mouth disinfection (FMD) approach | Other | non-surgical sub-marginal peri-implant instrumentation (NSPI) with FMD |
Primary outcome
Bleeding on probing (BOP) changes
Time frame: 6-months
The number of implants presenting with complete absence of BOP or implants with limited extent of BOP (≤1 spot/implant-the presence of a single spot)
5 secondary outcomes
Probing pocket depth (PPD) changes
Time frame: 6-months
Full mouth plaque score (FMPS) % changes
Time frame: 6-months
Full mouth bleeding score (FMBS) % changes
Time frame: 6-months
Plaque at implant sites according to modified gingival index (mGI) changes score
Time frame: 6-months
Plaque at implant sites according to modified plaque index (mPlI) changes score
Time frame: 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 19 Sep 2024.
- Derived from this study: PubMed 39865359Isola G, Polizzi A, Santagati M, Alibrandi A, Iorio-Siciliano V, Ramaglia L. Effect of Nonsurgical Mechanical Debridement With or Without Chlorhexidine Formulations in the Treatment of Peri-Implant Mucositis. A Randomized Placebo-Controlled Clinical Trial. Clin Oral Implants Res. 2025 May;36(5):566-577. doi: 10.1111/clr.14405. Epub 2025 Jan 25.
- Individual participant dataSharing planned: Yes. Results and clinical protocol
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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.
Gaetano Isola principal investigator
Università degli Studi di Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full mouth disinfection in people with Peri-implant Mucositis, run by University of Catania at 1 site in Italy.
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 5 inclusion and 6 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 Sep 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 Italy. 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?
Bleeding on probing (BOP) changes (time frame: 6-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 NCT05711576, which also lists 1 linked publication.
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 Sep 2024.