PeriodontitisNCT07474272
Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid
A study testing Standard Non-Surgical Periodontal Therapy, tandard Therapy + Sodium Hypochlorite/Amino Acid Gel and Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid in people with Periodontitis, run by Marwan El Mobadder at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Standard Non-Surgical Periodontal Therapy, tandard Therapy + Sodium Hypochlorite/Amino Acid Gel and Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteLebanon
- Study dates
- 11 Mar 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site
Dental Specialist' DS
Sidon, South of Lebanon
Marwan El Mobadder, Doctor (Ph.D), +33658940326, mobader.dds@gmail.com
About this study
Official title: Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite /Amino Acids and Cross-Linked Hyaluronic Acid: Randomized Controlled Trial
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?
Read more
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
Read the detailed description
Detailed Description
This study is a randomized controlled clinical trial designed to evaluate the effectiveness of adjunctive therapies in the non-surgical treatment of periodontitis. The trial compares three groups:
Standard non-surgical periodontal therapy (scaling and root planing with oral hygiene instruction).
Adjunctive sodium hypochlorite/amino acid gel applied before mechanical debridement.
Adjunctive sodium hypochlorite/amino acid gel followed by cross-linked hyaluronic acid ("Clean and Seal" protocol) after mechanical debridement.
The study aims to assess whether the use of these adjunctive treatments provides additional clinical benefits beyond standard therapy, measured through periodontal parameters such as plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), clinical attachment level (CAL), and gingival recession (GR).
Participants will be recruited from patients attending a dental clinic in Antwerp, Belgium. Randomization will be conducted at the time of enrollment using a pre-defined allocation scheme implemented in Microsoft Excel. Treatments will be performed by qualified dental professionals under standardized clinical conditions. Clinical measurements will be collected before intervention and at three months post-intervention by a calibrated examiner.
The trial is designed to provide robust clinical evidence regarding the efficacy and safety of sodium hypochlorite/amino acid gel alone and in combination with cross-linked hyaluronic acid as adjuncts to conventional non-surgical periodontal therapy. Findings may inform future clinical practice and contribute to optimizing non-surgical treatment protocols for periodontitis.
- Conditions
- Periodontitis
- Being tested
- Standard Non-Surgical Periodontal Therapy, tandard Therapy + Sodium Hypochlorite/Amino Acid Gel, Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid
- Keywords
- periodontal pocket, periodontitis, periodontal disease, deep periodontal pocket, localized periodontitis, generalized periodontitis, non-surgical treatment of periodontitis, non-surgical periodontal treatment
- Medical subject headings
- Periodontitis, Periodontal Pocket, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Non-Surgical Periodontal TherapyProcedure or surgery
Standard Non-Surgical Periodontal Therapy based on the American Academy of Periodontology's guidelines: mechanical debridement with manual and ultrasonics
tandard Therapy + Sodium Hypochlorite/Amino Acid GelProcedure or surgery
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 + Cross-Linked Hyaluronic AcidProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-operative and at 3 months post-operative
Secondary outcomes (4)
Plaque index (Silness et Loe)
The Plaque Index is a clinical measure of dental plaque accumulation on the surfaces of teeth. Each selected tooth surface is scored from 0 to 3 based on the thickness and visibility of plaque:
0: No plaque.
- A thin film of plaque adhering to the free gingival margin and adjacent tooth surface, only visible after running a probe across the surface.
- Moderate accumulation of plaque within the gingival pocket or on the tooth surface, visible to the naked eye.
- Abundant plaque accumulation within the gingival pocket and/or on the tooth and gingival margin.
In this study, PI will be recorded on four surfaces (mesial, distal, buccal, and lingual) of selected teeth (#16, #12, #24, #36, #32, #44). Scores for each tooth are summed and divided by the number of surfaces examined to obtain the mean PI, which reflects overall oral hygiene status.
Measured: pre-operative and 3 months post-operative
Bleeding on probing (BOP)
Bleeding on Probing is a clinical measure of gingival inflammation. A periodontal probe is gently inserted into the gingival sulcus or periodontal pocket at six sites per tooth (mesiobuccal, mid-buccal, distobuccal, mesiolingual/palatal, mid-lingual/palatal, distolingual/palatal).
Scoring: Each site is recorded as positive if bleeding occurs within 15 seconds after probing, and negative if no bleeding occurs.
The percentage of bleeding sites is calculated for each participant.
Timepoints: Measured at baseline (T0) and 3 months post-treatment (T3) to assess changes in gingival inflammation following therapy.
Measured: pre-operative and 3 months post-operative
gingival recession
Gingival Recession is the distance, in millimeters, from the cementoenamel junction (CEJ) to the free gingival margin.
Measurement: Taken at six sites per tooth using a calibrated periodontal probe.
Interpretation: A positive value indicates that the gingival margin is apical (toward the root) relative to the CEJ.
Gingival recession reflects loss of soft tissue coverage and is often associated with periodontal disease progression.
Measured: pre-operative and 3 months post-operative
Clinical attachment level
Clinical Attachment Level is a measure of periodontal tissue support and combines pocket depth and gingival recession.
Measurement: CAL is calculated as:
If gingival margin is at the CEJ: CAL = Probing Pocket Depth (PPD)
If gingival margin is apical to CEJ (recession): CAL = PPD + GR
If gingival margin is coronal to CEJ: CAL = PPD - distance from CEJ to gingival margin
Significance: CAL reflects the true attachment loss and is a key parameter for diagnosing and monitoring periodontitis.
Measured: Measured at baseline (T0) and 3 months post-treatment (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start11 Mar 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwan El Mobadder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwan El Mobadder, El Mobadder, Marwan, Ph.D., DDS
- Investigators
- Marwan El Mobadder, Doctor Ph.D, Study director, Department of Periodontology, Faculty of dental medicine, Lebanese UniversityKinga Grzech-Lesiniak, Ph.D (doctor), Study chair, Dental Surgery Department, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474272
- Sponsor's protocol ID
- MEMLB-NSPT-2026
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared due to the small sample size and the sensitive nature of patient-level clinical measurements. Sharing such data could risk participant confidentiality and privacy. Additionally, the study is investigator-initiated, and resources for secure anonymization, storage, and controlled access for external researchers are not available at this time.
Publications
Iorio-Siciliano V, Ramaglia L, Isola G, Blasi A, Salvi GE, Sculean A. Changes in clinical parameters following adjunctive local sodium hypochlorite gel in minimally invasive nonsurgical therapy (MINST) of periodontal pockets: a 6-month randomized controlled clinical trial. Clin Oral Investig. 2021 Sep;25(9):5331-5340. doi: 10.1007/s00784-021-03841-8. Epub 2021 Mar 9.
PubMed 33687555Ramanauskaite E, Machiulskiene Visockiene V, Shirakata Y, Friedmann A, Pereckaite L, Balciunaite A, Dvyliene UM, Vitkauskiene A, Baseviciene N, Sculean A. Microbiological Effects of Sodium Hypochlorite/-Amino Acids and Cross-linked Hyaluronic Acid Adjunctive to Non-surgical Periodontal Treatment. Oral Health Prev Dent. 2024 Apr 30;22:171-180. doi: 10.3290/j.ohpd.b5281925.
PubMed 38687029El 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.
PubMed 36295072Iorio-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 May;37(5):643-656. doi: 10.1111/clr.70109. Epub 2026 Feb 27.
PubMed 41761442
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite /Amino Acids and Cross-Linked Hyaluronic Acid: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07474272
- Acronym / sponsor ID
- MEMLB-NSPT-2026
- Conditions
- Periodontitis
- Keywords
- periodontal pocket, periodontitis, periodontal disease, deep periodontal pocket, localized periodontitis, generalized periodontitis, non-surgical treatment of periodontitis, non-surgical periodontal treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Marwan El MobadderUniversity, hospital or other
- Study start
- 11 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Detailed Description
This study is a randomized controlled clinical trial designed to evaluate the effectiveness of adjunctive therapies in the non-surgical treatment of periodontitis. The trial compares three groups:
Standard non-surgical periodontal therapy (scaling and root planing with oral hygiene instruction).
Adjunctive sodium hypochlorite/amino acid gel applied before mechanical debridement.
Adjunctive sodium hypochlorite/amino acid gel followed by cross-linked hyaluronic acid ("Clean and Seal" protocol) after mechanical debridement.
The study aims to assess whether the use of these adjunctive treatments provides additional clinical benefits beyond standard therapy, measured through periodontal parameters such as plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), clinical attachment level (CAL), and gingival recession (GR).
Participants will be recruited from patients attending a dental clinic in Antwerp, Belgium. Randomization will be conducted at the time of enrollment using a pre-defined allocation scheme implemented in Microsoft Excel. Treatments will be performed by qualified dental professionals under standardized clinical conditions. Clinical measurements will be collected before intervention and at three months post-intervention by a calibrated examiner.
The trial is designed to provide robust clinical evidence regarding the efficacy and safety of sodium hypochlorite/amino acid gel alone and in combination with cross-linked hyaluronic acid as adjuncts to conventional non-surgical periodontal therapy. Findings may inform future clinical practice and contribute to optimizing non-surgical treatment protocols for periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Standard Non-Surgical Periodontal TherapyParticipants 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. |
| Standard Therapy + Sodium Hypochlorite/Amino Acid Gel | Experimental | Procedure: tandard Therapy + Sodium Hypochlorite/Amino Acid GelParticipants 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. |
| Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid | Experimental | Procedure: Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic AcidParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Non-Surgical Periodontal TherapyStandard Non-Surgical Periodontal Therapy based on the American Academy of Periodontology's guidelines: mechanical debridement with manual and ultrasonics | Procedure or surgery | Control group |
| tandard Therapy + Sodium Hypochlorite/Amino Acid GelParticipants 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. | Procedure or surgery | Standard Therapy + Sodium Hypochlorite/Amino Acid Gel |
| Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic AcidParticipants 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. | Procedure or surgery | Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid |
Primary outcome
Probing Pocket Depth (PPD)
Time frame: pre-operative and at 3 months post-operative
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.
4 secondary outcomes
Plaque index (Silness et Loe)
Time frame: pre-operative and 3 months post-operative
Bleeding on probing (BOP)
Time frame: pre-operative and 3 months post-operative
gingival recession
Time frame: pre-operative and 3 months post-operative
Clinical attachment level
Time frame: Measured at baseline (T0) and 3 months post-treatment (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 33687555Iorio-Siciliano V, Ramaglia L, Isola G, Blasi A, Salvi GE, Sculean A. Changes in clinical parameters following adjunctive local sodium hypochlorite gel in minimally invasive nonsurgical therapy (MINST) of periodontal pockets: a 6-month randomized controlled clinical trial. Clin Oral Investig. 2021 Sep;25(9):5331-5340. doi: 10.1007/s00784-021-03841-8. Epub 2021 Mar 9.
- Background: PubMed 38687029Ramanauskaite E, Machiulskiene Visockiene V, Shirakata Y, Friedmann A, Pereckaite L, Balciunaite A, Dvyliene UM, Vitkauskiene A, Baseviciene N, Sculean A. Microbiological Effects of Sodium Hypochlorite/-Amino Acids and Cross-linked Hyaluronic Acid Adjunctive to Non-surgical Periodontal Treatment. Oral Health Prev Dent. 2024 Apr 30;22:171-180. doi: 10.3290/j.ohpd.b5281925.
- Background: PubMed 36295072El 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.
- Background: PubMed 41761442Iorio-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 May;37(5):643-656. doi: 10.1111/clr.70109. Epub 2026 Feb 27.
- 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 pLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared due to the small sample size and the sensitive nature of patient-level clinical measurements. Sharing such data could risk participant confidentiality and privacy. Additionally, the study is investigator-initiated, and resources for secure anonymization, storage, and controlled access for external researchers are not available at this time.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marwan El Mobadder, Doctor Ph.D study director
Department of Periodontology, Faculty of dental medicine, Lebanese University
Kinga Grzech-Lesiniak, Ph.D (doctor) study chair
Dental Surgery Department, Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Non-Surgical Periodontal Therapy, tandard Therapy + Sodium Hypochlorite/Amino Acid Gel and Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid in people with Periodontitis, run by Marwan El Mobadder at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwan El Mobadder, doctor (Ph.D) (+33658940326, mobader.dds@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (PPD) (time frame: pre-operative and at 3 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474272, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.