MucositisNCT06725095
Effects of Enamel Matrix Derivative in the Treatment of Peri-implant Mucositis
A study testing Enamel Matrix Proteins Derivative in people with Mucositis and 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 use of enamel matrix protein derivative (EMD). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucositis, Peri Implant Mucositis
- What is being tested?
- Enamel Matrix Proteins Derivative
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2024to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 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. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis
To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without use of enamel matrix protein derivative (EMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI +EMD with respect to NSPI and placebo in the treatment of PM at 6 months follow-up by means of BOP reduction. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.
Read the detailed description
Patients (n° 54) with Implants affected by PM were randomly assigned to test (NSMD+EMD) 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) will assessed as well as levels of periodontal bacteria such as Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola. 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
- Mucositis, Peri Implant Mucositis
- Being tested
- Placebo gel, Enamel Matrix Proteins Derivative
- Keywords
- Enamel matrix derivative
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelOther
Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo gel
Enamel Matrix Proteins DerivativeOther
Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of non-surgical treatment plus Enamel Matrix Proteins Derivative
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo gel | Placebo comparator | Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo Receives: Other: Placebo gel |
| non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD | Active comparator | Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD Receives: Other: Enamel Matrix Proteins Derivative |
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 (6)
Probing pocket depth (PPD) changes
Changes in PPD
Measured: 6-months
Full mouth plaque score (FMPS) % changes
Full mouth plaque score (FMPS) % changes
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
Patient-Reported Outcome Measures (PROMs)
Patient-Reported Outcome Measures (PROMs) Were evaluated PROMs such as the number of abscesses, systemic complications, gingival recession, excessive bleeding, allergic effects, systemic impacts and related drug side effects
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 posted10 Dec 2024
- Study start5 Dec 2024
- Primary completion1 Feb 2025
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
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, DDS, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725095
- Sponsor's protocol ID
- 2024-3306
- Status last verified
- May 2025
- First submitted
- 5 Dec 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pubmed
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis
- ClinicalTrials.gov ID
- NCT06725095
- Acronym / sponsor ID
- 2024-3306
- Conditions
- Mucositis, Peri Implant Mucositis
- Keywords
- Enamel matrix derivative
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 10 Dec 2024 (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 use of enamel matrix protein derivative (EMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI +EMD with respect to NSPI and placebo in the treatment of PM at 6 months follow-up by means of BOP reduction. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.
Detailed description
Patients (n° 54) with Implants affected by PM were randomly assigned to test (NSMD+EMD) 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) will assessed as well as levels of periodontal bacteria such as Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola. 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator: non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo gel | Placebo comparator | Other: Placebo gelPatients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo |
| non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD | Active comparator | Other: Enamel Matrix Proteins DerivativePatients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD |
Who may qualify
- Ages
- 18 to 75 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 (5 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; peri-implantitis (Berglundh et al., 2018)
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 gelPatients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo gel | Other | Placebo Comparator: non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo gel |
| Enamel Matrix Proteins DerivativePatients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of non-surgical treatment plus Enamel Matrix Proteins Derivative | Other | non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD |
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)
6 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
Patient-Reported Outcome Measures (PROMs)
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Yes. Pubmed
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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.
Gaetano Isola, DDS principal investigator
University of 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 Enamel Matrix Proteins Derivative in people with Mucositis and 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 5 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: enrolling by invitation, as of the sponsor's last update on 4 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
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 4 Jun 2025.