Polynucleotide + Hyaluronic Acid Gel With Xenogeneic Graft for Intrabony Periodontal Defects

NCT07522684 | Recruiting

• 2 other identifiers: 95039026.0.0000.5419MTA 25-030
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Level (CAL)

  Distance between the cemento-enamel junction and the bottom of the periodontal pocket/sulcus, in milimeters

  Baseline and 12 months

Secondary Outcomes (13)

• Probing depth (PD)

  Baseline and 12 months

• Changes in the alveolar bone crest

  Baseline and 12 months

• Radiographic defect depth

  Baseline and 12 months

• Vertical bone loss

  Baseline and 12 months

• Tomographic vertical bone loss

  Baseline and 12 months

Study Arms (3)

Control

ACTIVE COMPARATOR

Intrabony defects treated with open flap debridement alone

Other: Control

XENO

ACTIVE COMPARATOR

Intrabony defects treated with open flap debridement associated with xenogeneic bone grafting

Device: Xenogeneic bone graft

R-XENO

EXPERIMENTAL

Intrabony defects treated with open flap debridement associated with polynucleotide and hyaluronic acid-based gel plus xenogeneic bone grafting

Device: Polynucleotide and hyaluronic acid-based gel

Interventions

Polynucleotide and hyaluronic acid-based gel DEVICE

The polynucleotide and hyaluronic acid-based gel will be applied in combination with a xenogeneic bone graft to fill the intrabony defects.

R-XENO

Control OTHER

Intrabony defects treated with open flap debridement alone

Control

Xenogeneic bone graft DEVICE

The xenogeneic bone graft will be applied to fill the intrabony defects.

XENO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

Ribeirão Preto School of Dentistry, University of São Paulo

Ribeirão Preto, São Paulo, 14040904, Brazil

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Groups: Patients who meet the inclusion criteria will be randomly assigned to one of three experimental groups (n=22) in a 1:1 allocation ratio: Group C (Control), including intrabony defects treated with open flap debridement alone; Group XENO, including open flap debridement associated with xenogeneic bone grafting; and Group R-XENO, including open flap debridement associated with xenogeneic bone grafting and a PN/HA-containing gel. Randomization will be performed using software, which will identify each participant by a numerical code. Group allocation will be carried out on the day of surgery by the study coordinator.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: April 13, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)