RecruitingNot ApplicableNCT06309719

Hyaluronic Acid and Polynucleotides for Supra-bony Defects

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

Sponsor

Queen Mary University of London

Enrollment

24 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

Wound Heal Periodontal Diseases

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria11

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.

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Interventions

COMBINATION_PRODUCTPeriodontal 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

PROCEDUREPeriodontal 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