Hyaluronic Acid and Polynucleotides for Supra-bony Defects

NCT06309719 | Recruiting

• 1 other identifier: 339479
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel.

Conditions

Periodontal Diseases; Wound Heal; Periodontal Inflammation; Periodontal Pocket; Periodontal Attachment Loss

Outcome Measures

Primary Outcomes (2)

• Early wound healing molecular events through GCF

  Characterize the early wound healing molecular events through gingival crevicular fluid (GCF) biomarkers. In particular, the expression of specific biomarkers involved in the recruitment of osteoblast precursors, inflammatory-immune response, organization of extracellular matrix, cell adhesion, oxidative stress and angiogenesis. Multiplex immunoassays will be employed to simultaneously assess the expression of multiple proteins in GCF samples on the biological processes involved in early periodontal wound healing and the mechanism of action of PNHA, focusing on the expression of specific signalling pathways, including but not limited to TNF alpha, NF-kappa B, IL-17, TGF-beta, VEGF, HIF-1, Chemokine and Wnt signalling pathways.

  Baseline, 1, 4, 7, 15 days and 3 months after surgery from the deepest site of one tooth involved in the surgery

• Early gingival tissue vascularization pattern when supra-bony defects are treated with AF, in association or not with PNHA

  Blood flow changes in the surgical area will be evaluated with Laser Speckle Contrast Imaging (LSCI)

  Before and straight after completing the surgery, as well as at day 1, 4, 7, 15 and at 3 months

Secondary Outcomes (16)

• Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery

  Baseline and 3 months post-surgery

• Probing pocket depth (PPD)

  Baseline and 3 months post-surgery

• Gingival recession (REC)

  Baseline and 3 months post-surgery

• Clinical attachment level (CAL)

  Baseline and 3 months post-surgery

• Suppuration

  Baseline and 3 months post-surgery

Study Arms (2)

Test

EXPERIMENTAL

Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA)

Combination Product: Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA)

Control

ACTIVE COMPARATOR

Periodontal Access Flap (AF)

Procedure: Periodontal Access Flap (AF)

Interventions

Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) COMBINATION_PRODUCT

A conservative access flap will be performed such as simplified papilla preservation flap (SPPF). A PNHA gel will be placed on the root surfaces and supra-bony defects, followed by a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps by means of 5-0 suture

Test

Periodontal Access Flap (AF) PROCEDURE

A conservative access flap will be performed such as simplified papilla preservation flap (SPPF). No gel will be placed before suturing the flap by tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps by means of 5-0 suture

Control

Eligibility Criteria

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

You may qualify if:

• Systemically healthy males and females ≥18 years old
• Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)
• Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by a predominantly horizontal pattern of tissue destruction) confirmed clinically and radiographically at a minimum of two and a maximum of four adjacent teeth and with a probing pocket depth (PPD) \> 5 mm, following non-surgical periodontal therapy (NSPT). If \>4 adjacent teeth exhibited the above clinical and radiographic conditions, the four adjacent teeth showing the greatest overall loss of periodontal attachment were included. Wisdom teeth and second molars will not be considered for the study.
• If defect presents with an intrabony component, this should be ≤2 mm.
• Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months
• Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%

You may not qualify if:

• Teeth with degree III mobility
• Multi-rooted teeth with grade ≥2 furcation involvement
• Heavy smokers (≥10 cigarettes a day)
• Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery
• Previous periodontal surgery in the area selected for the study
• History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)
• Antibiotic or anticoagulant therapy during the month preceding the baseline exam.
• History of alcohol or drug abuse
• Medical history that includes uncontrolled diabetes or hepatic or renal diseases, or other serious medical conditions that can have a negative impact on the periodontal condition
• In treatment with medications that can severely affect bone metabolism and blood clot formation (e.g., anticoagulants, long-term corticosteroids, bisphosphonates, immunosuppressants)
• Self-reported pregnancy or lactation.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Geistlich Pharma AG: collaborator

Study Sites (2)

Barts Health NHS Trust Dental Hospital

London, E1 1BB, United Kingdom

RECRUITING

Centre for Oral Clinical Research (COCR)

London, E1 2AD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss

Interventions

Polydeoxyribonucleotides

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Elena Calciolari, DDS, MS, PhD

  QMUL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miljana Bacevic

CONTACT

+442078823063; BHNT.Clinicaloralresearchcentre@nhs.net

Elena Calciolari, DDS, MS, PhD

CONTACT

+442078823063; e.calciolari@qmul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 13, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

GB (2)