Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel

Study Overview
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Brief Summary
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The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up. After a meticulous selection, patients will be randomly assigned to Test (Sodium Hypochlorite-based gel + NSMD + Hyaluronic Acid-based gel ) or Control (NSMD) group. All clinical parameters will be recorded and the final evaluation will be performed.

Detailed Description
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The aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel (NaOCl gel) and a cross-linked hyaluronic acid-based gel (HA gel) as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up (Clean & Seal concept). Following the selection through inclusion and exclusion criteria, all patients will be randomly assigned to Test NaOCl-based gel + NSMD + HA-based gel) or Control (NSMD) group. Patients will be recruited at Department of Periodontology (Univeristy of Naples Federico II) and at Department of Periodontology (University of Budapest Semmelweis). Subsequently, after recording of the clinical parameters (BoP, FMPS, FMBS, PD), in the Test group a NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. Conversely, Control group will be treated only through the NSMD. All clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again after 6 months for the final evaluation. Data analysis will be performed using statistical software.

Official Title
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Treatment of Peri-implant Mucositis by Non-surgical Debridement and Adjunctive Application of a Combination of Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel

Conditions
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Peri-implant Mucositis, Mucositis Oral

Intervention / Treatment
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* Procedure: Application NaOCl gel + HA gel
* Procedure: Non-surgical mechanical debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Non-smokers and smokers ( ≤ 10 cigarettes/day); Presence of at least 1 implant in mucositis, clinically and radiographically detected; The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed. Exclusion Criteria: Cancer patients; Uncontrolled diabetic patients; Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months; Pregnant or breastfeeding patients; Implants that support mobile prosthetic products; Implants in peri-implantitis, detected clinically and radiographically.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with NaOCl-based gel + NSMD + HA-based gel in Test group and with NSMD alone in Control group. All clinical parameters will be recorded and the final evaluation will be performed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaOCl + HA Group<br>A NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, the HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. | Procedure: Application NaOCl gel + HA gel<br>* First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel<br>|
| Active Comparator: NSMD Group<br>Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips. | Procedure: Non-surgical mechanical debridement<br>* Only mechanical debridement with curettes ans scaler tips<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BoP (+/-) | Bleeding on periodontal probing | baseline, 6 months after periodontal therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Full-mouth Plaque Score (FMPS; %) | Percentage of all sites exhibiting plaque | baseline, 6 months after periodontal therapy | 
| Change of Full-mouth Bleeding Score (FMBS; %) | Percentage of all sites exhibiting bleeding | baseline, 6 months after periodontal therapy | 
| Change of Probing Depth (PD; millimeters). | Distance from the gingival margin to the bottom of the peri-implant pocket | baseline, 6 months after periodontal therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic Acid, Peri-implant mucositis, Sodium hypochlorite