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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High BMI and periodontitis in Thai adults under 60

  This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.

  Recruiting Mahidol University · Bangkok, Ratchathewi · NCT07880717

• Association Between Periodontitis and Dry Eye Disease in Adults

  This study tests whether periodontitis and dry eye disease are linked by comparing groups with and without each condition.

  Recruiting University of Sulaimani · Sulaymaniyah, As Sulaymaniyah Governorate · NCT07873697

• Periodontal Infection and Inflammatory Markers in Missed Abortion

  Researchers will test whether gum infection and inflammation are linked to missed abortion in pregnant women with no major chromosomal problems.

  Recruiting Necmettin Erbakan University · Konya, Konya · NCT07864220

• Smoking, MFN1, and NLRP3 Levels in Gum Fluid Across Periodontal Health and Disease

  This study tests whether smoking changes MFN1 and NLRP3 protein levels in the fluid around the gums for adults with or without periodontitis.

  Recruiting Abant Izzet Baysal University · Bolu, Central · NCT07826728

• Dental Loupes vs. Dental Operating Microscope for Non-Surgical Periodontal Treatment

  This study tests whether using dental loupes or a dental operating microscope makes non-surgical periodontal cleaning more effective for adults with periodontitis.

  Recruiting Saglik Bilimleri Universitesi · Ankara and 2 other locations · NCT07822269

• Boron, Oxidative Stress, and Inflammation in Periodontitis

  This observational study compares boron levels and inflammation markers in saliva and gum tissue between people with periodontitis and healthy controls to see if boron relates to gum inflammation.

  Recruiting Marmara University · Istanbul, Maltepe · NCT07775378

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.