Adjunctive Periodontal Therapy, Biofilm Control, Clinical Attachment Level, Gingivitis and Periodontal Diseases, Hyaluronic Acid, Hyaluronic Acid and Chlorhexidine Gel, Minimally Invasive Non-Surgical Therapy (MINST), Non-Surgical Periodontal Therapy, Periodontal Disease, Periodontal Diseases, Periodontitis (Stage 3), Periodontology, Periofix Plus Gel, Probing Pocket Depth, Stage III Periodontitis, Stage IV Periodontitis
Conditions
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
Brief 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. 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.
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.
Interventions
PROCEDUREMINST + CHX+HA gel
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)
PROCEDUREMINST
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth | 0, 3, 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level (CAL) | 0, 3, 6 months | 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). |
| Plaque index | 0, 3, 6 months | 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. |
| Bleeding on probing | 0, 3, 6 months | 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. |
| Gingival Marginal Level (GML) | 0, 3, 6 months | 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. |
| Post-operative Pain | 7 days | 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. |
Countries
Egypt
Contacts
STUDY_CHAIRKarim Fawzy Elsayed, PhD
Cairo University
Outcome results
None listed