Polynucleotide and hyaluronic acid gel with xenogeneic bone graft for treating intrabony periodontal defects

Effects of the Combination of a Polynucleotide and Hyaluronic Acid-Based Gel With Xenogeneic Bone Graft in the Treatment of Intrabony Defects in Patients With Periodontitis: a Randomized Controlled Clinical Trial.

This study tests whether adding a polynucleotide/hyaluronic acid gel plus a xenogeneic bone graft to open-flap debridement helps adults with stage III/IV periodontitis and intrabony defects heal better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Sao Paulo (Academic / other)
• Locations: 1 site (Ribeirão Preto, São Paulo)
• Trial ID: NCT07522684 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel-group clinical trial enrolling adults with stage III or IV periodontitis who have a 2- or 3-wall intrabony defect. Participants are randomized 1:1:1 to open-flap debridement alone, open-flap debridement with a xenogeneic bone graft, or open-flap debridement with a xenogeneic graft plus a polynucleotide/hyaluronic acid (PN/HA) gel. The trial is powered to detect a 1 mm difference in clinical attachment level and will measure clinical, radiographic/tomographic, immunologic, and patient-centered outcomes. A total of 66 patients (22 per group) are planned, with standardized surgical procedures and follow-up evaluations at prespecified time points.

Who should consider this trial

Good fit: Adults (≥18 years) with stage III or IV periodontitis, good plaque and bleeding control (FMPS and FMBS ≤20%), and a single 2- or 3-wall intrabony defect ≥3 mm with PD and CAL ≥5 mm are ideal candidates.

Not a fit: Patients with furcation involvement at the defect site, systemic conditions affecting healing, recent antimicrobial use, long-term immunosuppression, or poor oral hygiene are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination approach could improve periodontal tissue regeneration and bone fill, potentially improving tooth prognosis and reducing the need for additional treatment.

How similar studies have performed: Xenogeneic bone grafts and hyaluronic acid have prior supportive evidence for helping periodontal repair, but the addition of polynucleotides in this combination is relatively novel and less well tested.

Eligibility criteria

Inclusion Criteria:

* ≥ 18 years of age;
* diagnosis of periodontitis stage III or IV, grade B or C (Chapple et al., 2018; Papapanou et al., 2018);
* full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) of ≤ 20%;
* presence of a 2- or 3-wall intrabony defect with a depth ≥ 3 mm and probing depth and clinical attachment level ≥ 5 mm in the interproximal region of a single- or multi-rooted tooth;
* pulp vitality or satisfactory endodontic treatment in the tooth to be treated;
* at least 1 mm of keratinized tissue on the buccal surface of the tooth to be treated.

Exclusion Criteria:

* presence of furcation involvement associated with the intrabony defect;
* presence of systemic conditions that may affect the progression of periodontitis or the response to its treatment;
* long-term use of anti-inflammatory or immunosuppressive medications;
* use of antimicrobials within the last 6 months;
* continuous use of mouthwashes containing antimicrobial agents within the last 6 months;
* need for prophylactic antibiotic therapy for routine dental procedures;
* current or past tobacco use within the last 5 years;
* pregnancy;
* breastfeeding.

Where this trial is running

Ribeirão Preto, São Paulo

• Ribeirão Preto School of Dentistry, University of São Paulo — Ribeirão Preto, São Paulo, Brazil (Recruiting)

Conditions Periodontitis; Clinical Trial; Wound Healing; Polynucleotides; Hyaluronic Acid