NCT07522684 Polynucleotide + Hyaluronic Acid Gel With Xenogeneic Graft for Intrabony Periodontal Defects
| NCT ID | NCT07522684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2026-02-25 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Over the last 30 years, the prevalence of periodontitis (PE) has increased substantially, including among younger populations, highlighting the need to improve the management of this condition as a chronic disease and to develop techniques that favor its control and stability in the short and long term. After non-surgical periodontal therapy (NSPT), the first phase of PE treatment, residual periodontal pockets may persist, often associated with intraosseous defects, which compromise the tooth's prognosis and are associated with disease progression and increased treatment complexity. Surgical treatment of intrabony defects often results in the formation of long junctional epithelium, weakly attached to the root surface, since true regeneration of periodontal tissues is an unpredictable event and depends on complex biological processes. In recent decades, various biomaterials have been proposed as aids to open-flap debridement (OFD) in the surgical treatment of intrabony defects, with the aim of promoting periodontal regeneration, enhancing clinical results and favoring treatment prognosis. Recently, the combination of polynucleotides (PN) and hyaluronic acid (HA) has emerged as a promising auxiliary strategy to promote periodontal regeneration, due to its biological potential in stimulating cell growth and increasing cell viability. The aim of this controlled, randomized, parallel-group clinical study is to compare OFD alone with its association with xenogenous bone graft or xenogenous bone graft plus gel containing PN/HA in the surgical treatment of intrabony defects in patients with PE (stages III or IV, grades B or C). The patients will be randomly divided into three experimental groups (n=22): control (C), xenogeneic bone graft (XENO) and xenogeneic bone graft plus gel containing PN/HA (R-XENO). The patients will receive NSPT, and after eight weeks will undergo surgical procedures to treat the intrabony defects (baseline). Clinical, radiographic, tomographic and immunological periodontal parameters will be assessed at baseline and after 12 months. The wound healing index will be recorded 1, 2 and 6 weeks after the surgical procedure. Patient-centered outcomes will be assessed by means of a visual analog scale (VAS), applied two weeks after the surgical procedure, and oral health-related quality of life (OHRQoL) questionnaires, applied at the beginning of the study and after 6 and 12 months. At the start of the study and after 6 and 12 months, anthropometric data will be collected, blood pressure (BP) will be measured and questionnaires will be applied to survey socio-demographic and nutritional parameters. The data obtained will be statistically analyzed (p\<0.05).
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.
Frequently Asked Questions
Who can join the NCT07522684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07522684 currently recruiting?
Yes, NCT07522684 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Sao Paulo to inquire about joining.
Where is the NCT07522684 trial being conducted?
This trial is being conducted at Ribeirão Preto, Brazil.
Who is sponsoring the NCT07522684 clinical trial?
NCT07522684 is sponsored by University of Sao Paulo. The trial plans to enroll 66 participants.