Hyaluronic Acid and Polynucleotides for Supra-bony Defects

Official title

Characterizing the Healing of Periodontal Supra-bony Defects Treated With Hyaluronic Acid and Polynucleotides

Overview

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.

Detailed description

This is a parallel-group, pilot study aiming that consists of 7 visits over a minimum period of 4 months. Up to 24 periodontitis patients presenting with supra-bony defects will be recruited at the Centre for Oral Clinical Research (COCR) at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom.

Interventions

• Combination product Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA)
  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
• Procedure Periodontal Access Flap (AF)
  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

Primary outcome measures

• Early wound healing molecular events through GCF [Time frame: 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 [Time frame: Before and straight after completing the surgery, as well as at day 1, 4, 7, 15 and at 3 months]

Secondary outcome measures (12)

• Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery [Time frame: Baseline and 3 months post-surgery]
• Probing pocket depth (PPD) [Time frame: Baseline and 3 months post-surgery]
• Gingival recession (REC) [Time frame: Baseline and 3 months post-surgery]
• Clinical attachment level (CAL) [Time frame: Baseline and 3 months post-surgery]
• Suppuration [Time frame: Baseline and 3 months post-surgery]
• Gingival phenotype [Time frame: Baseline and 3 months post-surgery]
• Keratinized tissue (KT) [Time frame: Baseline and 3 months post-surgery]
• Full mouth plaque score (FMPS) [Time frame: Baseline and 3 months post-surgery]
• Full mouth bleeding score (FMBS) [Time frame: Baseline and 3 months post-surgery]
• Early Healing Index (EHI) [Time frame: Day 1, 4, 7 and 15 after the surgical intervention]
• Gingival morphometric changes [Time frame: Baseline visit, at 1, 4, 7, 15 days and 3 months post surgery]
• Oral impact on daily performance (OIDP) [Time frame: Baseline and at 3 months post surgery]

Eligibility criteria

Inclusion criteria

• 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%

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United Kingdom · 2 centers

• Barts Health NHS Trust Dental Hospital — London
• Centre for Oral Clinical Research (COCR) — London

Identifiers

NCT: NCT06309719 · 339479

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗