Hyaluronic Acid and Polynucleotides for Supra-bony Defects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Periodontal Diseases Wound Heal Periodontal Inflammation Periodontal Pocket Periodontal Attachment Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Test

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Control

Periodontal Access Flap (AF)

Group Type ACTIVE_COMPARATOR

Periodontal Access Flap (AF)

Intervention Type 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

Interventions

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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

Intervention Type COMBINATION_PRODUCT

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No