Peri-implant MucositisNCT04751565
Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants
A study testing Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy in people with Peri-implant Mucositis, run by University of Messina at 1 site in Italy.
Trial summary
This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 20 Dec 2021
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female aged > 18 years
- TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
- Implants placed in both arches
- Patients with gingivitis or treated periodontitis (i.e., absence of residual PD > 5 mm)
- Presence of at least 2 mm of keratinized mucosa at implant sites.
Who cannot join
- presence of medical conditions contraindicating treatment of peri-implant mucositis,
- regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment
- Presence of systemic diseases
- Pregnant and lactating females
- Smokers > 10 cigarettes/day
- Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
Show all 9Show fewer
- Implants with modified (i.e. micro-rough) necks
- Interproximal open contacts between implant restoration and adjacent teeth
- Peri-implantitis (Renvert, et al., 2018)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants
This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
Read the detailed description
Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.
Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.
- Conditions
- Peri-implant Mucositis
- Being tested
- Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleeding on Probing change reduction following peri-implant mucositis non surgical therapyOther
Statistically significant different in terms of Bleeding on Probing will be recorded between groups.
| Study group | Role | What they receive |
|---|---|---|
| Tissue level implant Group | Experimental | Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with tissue level implant
Primary outcome
The primary outcome will be based on probing depth (PD) Receives: Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy |
| Bone level implant Group | Experimental | Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with bone level implant
Primary outcome
The primary outcome will be the change in Bleeding on Probing (BOP) (Lang, Joss, Orsanic, Gusberti, Siegrist, 1986). Receives: Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing (BOP) changes
Changes over time in BOP changes (percentage)
Measured: Baseline (T0), 3-months (T1) and at 6-months (T2)
Secondary outcomes (1)
Full mouth plaque score (FMPS) changes
Chenges in Full mouth plaque score (FMPS) (parameter)
Measured: Baseline (T0), 3-months (T1) and at 6-months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Feb 2021
- Primary completion15 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Compare resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, DDS, PhD, University of Messina
- Investigators
- Gaetano Isola, Principal investigator, Università degli Studi di Mesina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751565
- Sponsor's protocol ID
- 2021-18/18
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing study results
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants
- ClinicalTrials.gov ID
- NCT04751565
- Acronym / sponsor ID
- 2021-18/18
- Conditions
- Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 12 Feb 2021 (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.
This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
Detailed description
Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.
Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Compare resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
| Arm | Type | Receives |
|---|---|---|
| Tissue level implant Group | Experimental | Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapyEvaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with tissue level implant Primary outcome The primary outcome will be based on probing depth (PD) |
| Bone level implant Group | Experimental | Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapyEvaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with bone level implant Primary outcome The primary outcome will be the change in Bleeding on Probing (BOP) (Lang, Joss, Orsanic, Gusberti, Siegrist, 1986). |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female aged > 18 years
- TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
- Implants placed in both arches
- Patients with gingivitis or treated periodontitis (i.e., absence of residual PD > 5 mm)
- Presence of at least 2 mm of keratinized mucosa at implant sites.
Key exclusion criteria (9 listed)
- presence of medical conditions contraindicating treatment of peri-implant mucositis,
- regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment
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 |
|---|---|---|
| Bleeding on Probing change reduction following peri-implant mucositis non surgical therapyStatistically significant different in terms of Bleeding on Probing will be recorded between groups. | Other | Bone level implant Group, Tissue level implant Group |
Primary outcome
Bleeding on Probing (BOP) changes
Time frame: Baseline (T0), 3-months (T1) and at 6-months (T2)
Changes over time in BOP changes (percentage)
1 secondary outcome
Full mouth plaque score (FMPS) changes
Time frame: Baseline (T0), 3-months (T1) and at 6-months (T2)
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 28 Feb 2023.
- Individual participant dataSharing planned: Yes. Sharing study results
Related trials for Peri-implant Mucositis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruiting
Adjunctive Diode Laser Therapy for Peri-Implant Mucositis
Peri-implant Mucositis
Not yet recruitingObservational study
Short Versus Standard Dental Implants: Clinical and Biomarker Outcomes
Peri-Implant Mucositis
RecruitingObservational study
Impact of Smoking on Immune Responses in Peri-implant Health and Disease
Peri-Implant Health, Peri Implant Mucositis
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 Mesina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy in people with Peri-implant Mucositis, run by University of Messina 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 9 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 28 Feb 2023. 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. 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: Baseline (T0), 3-months (T1) and at 6-months (T2)). 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 28 Feb 2023.