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

Peri-implant Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926297
• Other study ID #: 110/2023
• Secondary ID: 140/2023
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: Luca Ramaglia
• Phone: +393476912911
• Email: luca.ramaglia[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: January 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Mucositis Oral
• Peri-implant Mucositis
• Stomatitis

Intervention

Procedure:
• Application NaOCl gel + HA gel
First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel
• Non-surgical mechanical debridement
Only mechanical debridement with curettes ans scaler tips

Locations

Country	Name	City	State
Hungary	Semmelweis University	Budapest	HU
Italy	University of Naples Federico II	Naples

Sponsors (2)

Lead Sponsor	Collaborator
Federico II University	Semmelweis University

Countries where clinical trial is conducted

Hungary,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of BoP (+/-)	Bleeding on periodontal probing	baseline, 6 months after periodontal therapy
Secondary	Change of Full-mouth Plaque Score (FMPS; %)	Percentage of all sites exhibiting plaque	baseline, 6 months after periodontal therapy
Secondary	Change of Full-mouth Bleeding Score (FMBS; %)	Percentage of all sites exhibiting bleeding	baseline, 6 months after periodontal therapy
Secondary	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