Clinical trial NCT06309719: Hyaluronic Acid and Polynucleotides for Supra-bony Defects
Official title: Characterizing the Healing of Periodontal Supra-bony Defects Treated With Hyaluronic Acid and Polynucleotides
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Wound Heal
Periodontal Inflammation
Periodontal Pocket
Periodontal Attachment Loss
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
First posted: 2024-03-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Early wound healing molecular events through GCF
timeFrame: Baseline, 1, 4, 7, 15 days and 3 months after surgery from the deepest site of one tooth involved in the surgery
measure: Early gingival tissue vascularization pattern when supra-bony defects are treated with AF, in association or not with PNHA
timeFrame: Before and straight after completing the surgery, as well as at day 1, 4, 7, 15 and at 3 months
Secondary outcomes:
measure: Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery
timeFrame: Baseline and 3 months post-surgery
measure: Probing pocket depth (PPD)
timeFrame: Baseline and 3 months post-surgery
measure: Gingival recession (REC)
timeFrame: Baseline and 3 months post-surgery
measure: Clinical attachment level (CAL)
timeFrame: Baseline and 3 months post-surgery
measure: Suppuration
timeFrame: Baseline and 3 months post-surgery
measure: Gingival phenotype
timeFrame: Baseline and 3 months post-surgery
measure: Keratinized tissue (KT)
timeFrame: Baseline and 3 months post-surgery
measure: Full mouth plaque score (FMPS)
timeFrame: Baseline and 3 months post-surgery
measure: Full mouth bleeding score (FMBS)
timeFrame: Baseline and 3 months post-surgery
measure: Early Healing Index (EHI)
timeFrame: Day 1, 4, 7 and 15 after the surgical intervention
measure: Gingival morphometric changes
timeFrame: Baseline visit, at 1, 4, 7, 15 days and 3 months post surgery
measure: Oral impact on daily performance (OIDP)
timeFrame: Baseline and at 3 months post surgery
measure: Dentine/root sensitivity
timeFrame: Baseline and at 3 months post-surgery
measure: Food impaction
timeFrame: Baseline and at 3 months post-surgery
measure: Patient perception about therapy
timeFrame: At day 1, 4, 7 and 15 after surgical therapy
measure: Global ratings of Periodontal Health and Quality of Life
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust Dental Hospital
city: London
country: United Kingdom
facility: Centre for Oral Clinical Research (COCR)
Study officials:
affiliation: QMUL
name: Elena Calciolari, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: