Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid

NCT07474272 | Not Yet Recruiting DMC

• 1 other identifier: MEMLB-NSPT-2026
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if using sodium hypochlorite/amino acid gel, with or without cross-linked hyaluronic acid, as an addition to standard non-surgical periodontal therapy works to treat periodontitis in adults. It will also learn about the safety of these treatments. The main questions it aims to answer are: Does the adjunctive treatment reduce bleeding on probing, plaque index, and periodontal pocket depth? What medical or dental problems do participants have when receiving these treatments? Researchers will compare: Standard non-surgical periodontal therapy alone Standard therapy plus sodium hypochlorite/amino acid gel Standard therapy plus sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid ("Clean and Seal" protocol) Participants will: Receive their assigned treatment during one clinical session per the study protocol Have clinical measurements taken before treatment and at three months after treatment Be monitored for any dental or medical adverse events related to the procedures

Conditions

Periodontitis

Keywords

periodontal pocket; periodontitis; periodontal disease; deep periodontal pocket; localized periodontitis; generalized periodontitis; non-surgical treatment of periodontitis; non-surgical periodontal treatment

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth (PPD)

  Probing Pocket Depth is the distance, measured in millimeters, from the gingival margin (the edge of the gum tissue) to the bottom of the periodontal pocket, which is the point where the soft tissue attaches to the tooth. It is measured using a calibrated periodontal probe at six sites per tooth: mesiobuccal, mid-buccal, distobuccal, mesiolingual/palatal, mid-lingual/palatal, and distolingual/palatal.

  pre-operative and at 3 months post-operative

Secondary Outcomes (4)

• Plaque index (Silness et Loe)

  pre-operative and 3 months post-operative

• Bleeding on probing (BOP)

  pre-operative and 3 months post-operative

• gingival recession

  pre-operative and 3 months post-operative

• Clinical attachment level

  Measured at baseline (T0) and 3 months post-treatment (T3).

Study Arms (3)

Control group

ACTIVE COMPARATOR

Participants receive standard care, including oral hygiene instructions, supragingival and subgingival mechanical debridement using ultrasonic and hand instruments, and brief irrigation with 0.12% chlorhexidine solution. No adjunctive sodium hypochlorite or hyaluronic acid is used.

Procedure: Standard Non-Surgical Periodontal Therapy

Standard Therapy + Sodium Hypochlorite/Amino Acid Gel

EXPERIMENTAL

Participants receive the same standard care as Arm 1. In addition, a 0.9% sodium hypochlorite/amino acid gel (Perisolv) is instilled into periodontal pockets with probing depth \>4 mm and left for 60 seconds before mechanical debridement. The gel application is repeated as needed until instrumentation is complete.

Procedure: tandard Therapy + Sodium Hypochlorite/Amino Acid Gel

Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid

EXPERIMENTAL

Participants receive the same treatment as Arm 2. After instrumentation, cross-linked hyaluronic acid gel (Hyadent BG) is applied to the treated pockets to promote healing and tissue regeneration, following the "Clean and Seal" protocol.

Procedure: Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid

Interventions

Standard Non-Surgical Periodontal Therapy PROCEDURE

Standard Non-Surgical Periodontal Therapy based on the American Academy of Periodontology's guidelines: mechanical debridement with manual and ultrasonics

Control group

tandard Therapy + Sodium Hypochlorite/Amino Acid Gel PROCEDURE

Participants receive the same standard care as Arm 1. In addition, a 0.9% sodium hypochlorite/amino acid gel is instilled into periodontal pockets with probing depth \>4 mm and left for 60 seconds before mechanical debridement. The gel application is repeated as needed until instrumentation is complete.

Standard Therapy + Sodium Hypochlorite/Amino Acid Gel

Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid PROCEDURE

Participants receive the same treatment as Arm 2. After instrumentation, cross-linked hyaluronic acid gel is applied to the treated pockets to promote healing and tissue regeneration, following the "Clean and Seal" protocol.

Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Localized periodontal pocket with a probing depth ≥ 6 mm and a clinical - attachment loss of \> 3 mm (periodontitis stage III or IV; classification of the European Federation of Periodontology and American Academy of Periodontology);
• Patients who signed the written informed consent and is willing to cooperate;
• Bleeding on probing in more than 30% of the sites.

You may not qualify if:

• Medical history likely to affect periodontal status and/or to compromise treatment outcomes;
• Patients who received antibiotic and/or anti-inflammatory treatments the last 6 months
• Patients who received immunosuppressors treatments the last 6 months;
• Patients who received any periodontal therapy for the last 6 months;
• Pregnant or lactating women;
• Smokers smoking more than 10 cigarettes per day.

Sponsors & Collaborators

• Marwan El Mobadder: lead

Study Sites (1)

Dental Specialist' DS

Sidon, South of Lebanon, Lebanon

Location

Related Publications (4)

• Iorio-Siciliano V,Ramaglia L,Isola G,Blasi A,Salvi GE,Sculean A

  BACKGROUND

• Ramanauskaite E,Machiulskiene Visockiene V,Shirakata Y,Friedmann A,Pereckaite L,Balciunaite A,Dvyliene UM,Vitkauskiene A,Baseviciene N,Sculean A

  BACKGROUND

• El Mobadder M, Nammour S, Matys J, Grzech-Lesniak K. Sodium Hypochlorite and Diode Laser in Non-Surgical Treatment of Periodontitis: Clinical and Bacteriological Study with Real Time Polymerase Chain Reaction (PCR). Life (Basel). 2022 Oct 19;12(10):1637. doi: 10.3390/life12101637.

  PMID: 36295072 BACKGROUND

• Iorio-Siciliano V, Blasi A, Mauriello L, Windisch P, Salvi GE, Sculean A, Ramaglia L. Non-Surgical Submarginal Instrumentation of Peri-Implant Mucositis With Delivery of Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Feb 27. doi: 10.1111/clr.70109. Online ahead of print.

  PMID: 41761442 BACKGROUND

Related Links

• This link provides official information from Regedent on the "Clean and Seal" protocol, which uses a sodium hypochlorite/amino acid gel followed by cross-linked hyaluronic acid as an adjunct to standard non-surgical periodontal therapy. It explains the p

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket; Periodontal Diseases

Interventions

Sodium Hypochlorite; Standard of Care

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marwan El Mobadder, Doctor Ph.D

  Department of Periodontology, Faculty of dental medicine, Lebanese University

  STUDY DIRECTOR

• Kinga Grzech-Lesiniak, Ph.D (doctor)

  Dental Surgery Department, Wroclaw Medical University

  STUDY CHAIR

Central Study Contacts

Marwan El Mobadder, doctor (Ph.D)

CONTACT

+33658940326; mobader.dds@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable; all procedures are open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Specialist in Periodontal and Implant Therapies

Model Details: The trial has three parallel arms: standard care, standard care plus sodium hypochlorite/amino acid gel, and standard care plus sodium hypochlorite/amino acid gel + cross-linked hyaluronic acid ("Clean and Seal" protocol). Participants remain in their assigned group for the duration of the study.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)