Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion criteria: 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 Implants with modified (i.e. micro-rough) necks Interproximal open contacts between implant restoration and adjacent teeth Peri-implantitis (Renvert, et al., 2018)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue level implant Group<br>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) | Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy<br>* Statistically significant different in terms of Bleeding on Probing will be recorded between groups.<br>|
| Experimental: Bone level implant Group<br>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). | Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy<br>* Statistically significant different in terms of Bleeding on Probing will be recorded between groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on Probing (BOP) changes | Changes over time in BOP changes (percentage) | Baseline (T0), 3-months (T1) and at 6-months (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full mouth plaque score (FMPS) changes | Chenges in Full mouth plaque score (FMPS) (parameter) | Baseline (T0), 3-months (T1) and at 6-months (T2) |