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

Sponsor

Federico II University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05926297

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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 (NaOCl-based gel + NSMD + HA-based gel ) or Control (NSMD) group. All clinical parameters will be recorded and the final evaluation will be performed.

Condition or Disease	Intervention/Treatment	Phase
Peri-implant Mucositis Mucositis Oral	Procedure: Application NaOCl gel + HA gel Procedure: Non-surgical mechanical debridement	N/A

Detailed Description

The aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel and a cross-linked hyaluronic acid-based gel as an adjuvant to 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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Masking Description:

Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NaOCl + HA 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, 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 First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel
Active Comparator: NSMD Group Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.	Procedure: Non-surgical mechanical debridement Only mechanical debridement with curettes ans scaler tips

Arm

Intervention/Treatment

Experimental: NaOCl + HA 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, 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

First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel

Active Comparator: NSMD Group

Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.

Procedure: Non-surgical mechanical debridement

Only mechanical debridement with curettes ans scaler tips

Outcome Measures

Primary Outcome Measures

Change of BoP (+/-) [baseline, 6 months after periodontal therapy]
Bleeding on periodontal probing

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Naples Federico II	Naples		Italy	80131

Sponsors and Collaborators

Federico II University

Investigators

Principal Investigator: Luca Ramaglia, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luca Ramaglia, Clinical Professor, Federico II University

ClinicalTrials.gov Identifier:

NCT05926297

Other Study ID Numbers:

110/2023

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 5, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Luca Ramaglia, Clinical Professor, Federico II University

Hyaluronic Acid

Peri-implant mucositis

Sodium hypochlorite

Additional relevant MeSH terms:

Mucositis

Stomatitis

Study Results

No Results Posted as of Jul 5, 2023