PeriodontologyNCT07731113
Evaluation of Hyaluronic Acid and Chlorhexidine Gel as an Adjunct to Minimally Invasive Non-surgical Therapy in the Treatment of Stage III and IV Periodontitis
A study testing MINST + CHX+HA gel and MINST in people with Periodontology and Periodontal Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Stage III and IV periodontitis are advanced forms of periodontal disease characterized by significant attachment loss, deep periodontal pockets, and progressive destruction of supporting periodontal tissues. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Periodontology, Periodontal Disease, Periodontal Diseases
- What is being tested?
- MINST + CHX+HA gel and MINST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 30 Dec 2026
- Phase
- Interventional
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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-70
- Diagnosis of 'periodontitis' stage III or IV (grades A to C)
- Presence of ≥ 1 'intrabony defect' (PPD, > 5 mm with intrabony defect depth ≥ 3 mm at screening radiograph)
- Signed informed consent
Who cannot join
- Smoking (current or in past 5 years)
- Medical history including diabetes or hepatic or renal disease or other serious medical conditions or transmittable diseases
- History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
- Systemic antibiotic therapy during the 3 months preceding the baseline exam
- History of alcohol or drug abuse
Show all 9Show fewer
- Self-reported pregnancy or lactation
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation
- Periodontal treatment to the study site within the last 12 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine. Cairo University
Giza, Giza Governorate
About this study
Official title: Evaluation of Hyaluronic Acid and Chlorhexidine Gel as an Adjunct to Minimally Invasive Non-surgical Therapy in the Treatment of Stage III and IV Periodontitis: A Randomized Clinical Trial
Stage III and IV periodontitis are advanced forms of periodontal disease characterized by significant attachment loss, deep periodontal pockets, and progressive destruction of supporting periodontal tissues. Minimally invasive non-surgical therapy (MINST) has been proposed as an effective treatment approach aimed at minimizing tissue trauma while achieving optimal biofilm and calculus removal. Adjunctive therapies may further enhance clinical outcomes by promoting wound healing and reducing inflammation.
This randomized clinical trial aims to evaluate the effectiveness of a hyaluronic acid and chlorhexidine gel (Periofix Plus Gel) used as an adjunct to MINST in patients with Stage III and IV periodontitis. Participants will be randomly assigned to receive either MINST alone or MINST combined with local application of the hyaluronic acid/chlorhexidine gel. Clinical periodontal parameters, including probing pocket depth, clinical attachment level, bleeding on probing, and plaque-related indices, will be assessed at baseline and follow-up visits to determine whether adjunctive gel application provides additional clinical benefits compared with MINST alone.
The study hypothesis is that the adjunctive use of hyaluronic acid and chlorhexidine gel following MINST will result in greater periodontal pocket reduction, improved clinical attachment gain, and enhanced soft tissue healing compared with MINST alone.
Read the detailed description
A tendency to perform increasingly less traumatic procedures (like MINST) that preserve hard and soft periodontal tissues is being observed in periodontology, significantly improving the visualization and root decontamination, reducing inflammation and probing depth, and at the same time preserving the gingival margin and consequently improving the aesthetic results.
In the literature, extracellular matrix components and various local agents have been explored as adjuncts to periodontal treatment. The unique physiochemical properties of hyaluronic acid (HA) have led to its frequent use in medical applications for many years. HA, a natural extracellular matrix constituent, plays a crucial role in periodontal health. It has anti-inflammatory, anti-edematous, and antibacterial properties particularly in relation to periodontal diseases arising from the interplay between the host and microbial dental biofilm. Studies suggest that HA enhances the viability of periodontal ligament (PDL) cells, preserves osteogenic differentiation, strongly promotes the proliferation of osteoprogenitor cells, and potentially aiding in regeneration of periodontal bone defects.
CHX is the most potent chemical plaque control agent that has various clinical applications in periodontics. Its broad antimicrobial spectrum can be considered as boon for maintaining overall oral health. Moreover, CHX has proven to be an extremely useful antimicrobial in the field of health. Locally administered and sustained CHX in the form of CHX chips is the most advantageous for long-term use as an adjunct to oral hygiene in patients with periodontitis (stage I-III).
The control group will receive MINST only for the treatment of deep periodontal pockets. The application of MINST minimizes soft and hard tissue trauma achieving better treatment outcomes in comparison with traditional scaling and root planing. Gingival architecture is maintained, and stability of the area is preserved favoring better clot formation and stabilization.
- Conditions
- Periodontology, Periodontal Disease, Periodontal Diseases, Periodontitis (Stage 3), Gingivitis and Periodontal Diseases, Stage III Periodontitis
- Being tested
- MINST + CHX+HA gel, MINST
- Keywords
- MINST, Minimally invasive non-surgical technique, Periodontitis treatment, Stage III Periodontitis, Stage IV Periodontitis, Minimally Invasive Non-Surgical Therapy (MINST), Non-Surgical Periodontal Therapy, Hyaluronic Acid, Chlorhexidine, Hyaluronic Acid and Chlorhexidine Gel, Periofix Plus Gel, Adjunctive Periodontal Therapy, Periodontal Pocket, Clinical Attachment Level, Probing Pocket Depth, Periodontal Regeneration, Wound Healing, Biofilm Control, Randomized Clinical Trial, Periodontal Treatment
- Medical subject headings
- Periodontal Diseases, Periodontitis, Gingivitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINST + CHX+HA gelProcedure or surgery
Also called Minimally invasive non surgical therapy + (CHX+HA)
Test intervention (MINST + CHX+HA gel):
Participants will receive Minimally Invasive Non-Surgical Therapy (MINST) for the treatment of deep periodontal pockets. Immediately after instrumentation, a chlorhexidine (CHX) and hyaluronic acid (HA) gel will be applied subgingivally into the treated periodontal pockets as an adjunct to MINST. The gel is intended to provide local antimicrobial activity while supporting soft tissue healing and periodontal wound repair.
Gel used: Periofix Plus GEL (Intermed S.A. Pharmaceutical Laboratories, Greece)
MINSTProcedure or surgery
MINST is a non-surgical periodontal treatment performed using delicate instrumentation and magnification to selectively remove subgingival biofilm and calculus while minimizing trauma to the soft and hard tissues. The technique aims to preserve gingival architecture, promote stable blood clot formation, and optimize periodontal wound healing in deep periodontal pockets
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control group will receive MINST only for the treatment of deep periodontal pockets. The application of MINST minimizes soft and hard tissue trauma achieving better treatment outcomes in comparison with traditional scaling and root planing. Gingival architecture is maintained, and stability of the area is preserved favoring better clot formation and stabilization Receives: Procedure: MINST |
| Test | Experimental | Test intervention (MINST + CHX+HA gel): Participants will receive Minimally Invasive Non-Surgical Therapy (MINST) for the treatment of deep periodontal pockets. Immediately after instrumentation, a chlorhexidine (CHX) and hyaluronic acid (HA) gel will be applied subgingivally into the treated periodontal pockets as an adjunct to MINST. The gel is intended to provide local antimicrobial activity while supporting soft tissue healing and periodontal wound repair. Gel used: Periofix Plus GEL (Intermed S.A. Pharmaceutical Laboratories, Greece) Receives: Procedure: MINST + CHX+HA gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Measured from the gingival margin to the bottom of the gingival sulcus. Each tooth will be probed with a light force not exceeding 25 grams at 6 sites
Measured: 0, 3, 6 months
Secondary outcomes (5)
Clinical attachment level (CAL)
Measured from the CEJ to the bottom of the gingival sulcus (Ramfjord, 1967b), or will be calculated as the algebraic sum of gingival recession and PD measurements for each site. Each tooth will be probed with a light force not exceeding 25 grams at six points: (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual).
Measured: 0, 3, 6 months
Plaque index
Dental plaque accumulation will be assessed using the Plaque Index (PI). This index evaluates the presence and thickness of plaque at the gingival margin on selected tooth surfaces, providing a measure of the participant's oral hygiene status. Lower scores indicate better plaque control.
Scoring Criteria:
Score 0: No plaque on the tooth surface. Score 1: A thin film of plaque seen only when you scrape the tooth with a probe.
Score 2: Moderate plaque deposits that you can see with the naked eye. Score 3: Lots of thick soft matter filling the area.
Measured: 0, 3, 6 months
Bleeding on probing
Gingival bleeding will then be assessed. Gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to 2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
Measured: 0, 3, 6 months
Gingival Marginal Level (GML)
Gingival Marginal Level (GML) will be measured as the distance from a fixed reference point, typically the cementoenamel junction (CEJ), to the gingival margin using a calibrated periodontal probe. This measurement is used to assess changes in gingival margin position, including gingival recession or coronal tissue gain, over the study period.
Measured: 0, 3, 6 months
Post-operative Pain
Patient-reported pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst pain imaginable." Participants will be asked to mark the point on the scale that best reflects their perceived pain level related to the periodontal condition and/or treatment. The distance in centimeters from the zero point to the patient's mark will be recorded as the pain score.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Mar 2026
- Primary completion10 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontologyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mamdouh Kamal Ali, Cairo University
- Investigators
- Karim Fawzy Elsayed, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731113
- Sponsor's protocol ID
- PER 3-3-1.1
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality considerations and the absence of a formal data-sharing plan.
Publications
Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.
PubMed 31351492Mehta J, Montevecchi M, Garcia-Sanchez R, Onabolu O, Linares A, Eriksson F, Ghezzi C, Donghi C, Lu EM, Nibali L. Minimally invasive non-surgical periodontal therapy of intrabony defects: A prospective multi-centre cohort study. J Clin Periodontol. 2024 Jul;51(7):905-914. doi: 10.1111/jcpe.13984. Epub 2024 May 6.
PubMed 38710583