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

Not Applicable

Recruiting

• Conditions: Peri-implant Mucositis; Mucositis Oral
• Interventions: Procedure: Non-surgical mechanical debridement; Procedure: Application NaOCl gel + HA gel

• Registration Number: NCT05926297
• Lead Sponsor: Federico II University

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-06-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSMD Group	Non-surgical mechanical debridement	Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.
NaOCl + HA Group	Application NaOCl gel + HA gel	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.

Primary Outcome Measures

Name	Time	Method
Change of BoP (+/-)	baseline, 6 months after periodontal therapy	Bleeding on periodontal probing

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Semmelweis University; 🇭🇺 Budapest, HU, Hungary

University of Naples Federico II; 🇮🇹 Naples, Italy