Hyaluronic Acid and Polynucleotides for Supra-bony Defects

June 6, 2025 updated by: Queen Mary University of London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
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)
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
Active Comparator: Control
Periodontal Access Flap (AF)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Before and straight after completing the surgery, as well as at day 1, 4, 7, 15 and at 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery
Time Frame: Baseline and 3 months post-surgery
PISA reflects the surface area of bleeding pocket epithelium in square millimetres. PISA is calculated using conventional clinical attachment levels (CAL), recession (REC) and bleeding on probing (BOP) measurements. PISA quantifies the amount of inflamed periodontal tissue, thereby quantifying the inflammatory burden posed by periodontitis. The higher the number, the more inflamed periodontal tissue. The periodontal inflamed surface area (PISA) is the sum of the PPD of bleeding on probing (BOP)-positive sites for the total dentition and can be easily calculated using routine periodontal charting.
Baseline and 3 months post-surgery
Probing pocket depth (PPD)
Time Frame: Baseline and 3 months post-surgery
PPD will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/ implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual).
Baseline and 3 months post-surgery
Gingival recession (REC)
Time Frame: Baseline and 3 months post-surgery
REC will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/ implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual).
Baseline and 3 months post-surgery
Clinical attachment level (CAL)
Time Frame: Baseline and 3 months post-surgery
CAL will be calculated considering the values for PPD and REC in mm
Baseline and 3 months post-surgery
Suppuration
Time Frame: Baseline and 3 months post-surgery
Suppuration will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of suppuration following periodontal probing. A binary score will be assigned to each surface (1 for suppuration present, 0 for suppuration absent).
Baseline and 3 months post-surgery
Gingival phenotype
Time Frame: Baseline and 3 months post-surgery
Gingival phenotype of the teeth involved in the surgery will be defined as thin (≤1.0 mm) or thick (>1mm) upon the observation of the periodontal probe through the gingival tissue
Baseline and 3 months post-surgery
Keratinized tissue (KT)
Time Frame: Baseline and 3 months post-surgery
Keratinized tissue width will be assessed in mm with a periodontal probe measuring from the mucogingival junction to the free gingival margin.
Baseline and 3 months post-surgery
Full mouth plaque score (FMPS)
Time Frame: Baseline and 3 months post-surgery
FMPS will be recorded as a percentage of total surfaces (6 sites per tooth/implant), which reveal the presence of plaque. A binary score will be assigned to each surface (1 for plaque present, 0 for absent).
Baseline and 3 months post-surgery
Full mouth bleeding score (FMBS)
Time Frame: Baseline and 3 months post-surgery
FMBS will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of bleeding within 10 - 30 seconds following periodontal probing. A binary score will be assigned to each surface (1 for bleeding present, 0 for bleeding absent).
Baseline and 3 months post-surgery
Early Healing Index (EHI)
Time Frame: Day 1, 4, 7 and 15 after the surgical intervention

The surgical wound will be graded as follows:

  1. complete flap closure - no fibrin line in the interproximal area
  2. complete flap closure - fine fibrin line in the interproximal area
  3. complete flap closure - fibrin clot in the interproximal area
  4. incomplete flap closure - partial necrosis of the interproximal tissue
  5. incomplete flap closure - complete necrosis of the interproximal tissue.
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
An intra-oral 3D scanner will be used to capture and monitor soft tissue contour changes during early phase of healing. A series of subtracted images from the baseline to the subsequent follow-ups will accurately identify the area and magnitude of the swelling, changes in shape and volume to monitor/quantify the healing.
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
OIDP focuses on the impact that the conditions of the teeth and mouth have on the physical (functional), psychological and social wellbeing of the person. For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life.
Baseline and at 3 months post surgery
Dentine/root sensitivity
Time Frame: Baseline and at 3 months post-surgery
A 100-mm horizontal visual analog scale (VAS) will be used to assess dentine/root sensitivity. The anchors for each end of the scales will be designated as none and extreme.
Baseline and at 3 months post-surgery
Food impaction
Time Frame: Baseline and at 3 months post-surgery
A 100-mm horizontal visual analog scale (VAS) will be used to assess food impaction. The anchors for each end of the scales will be designated as none and extreme.
Baseline and at 3 months post-surgery
Patient perception about therapy
Time Frame: At day 1, 4, 7 and 15 after surgical therapy
the extent of discomfort and/or pain experienced will be evaluated using a 100-mm VAS. The anchors for each end of the scales will be designated as none and extreme.
At day 1, 4, 7 and 15 after surgical therapy
Global ratings of Periodontal Health and Quality of Life
Time Frame: 3 months after surgery
Periodontal health and quality of life following periodontal therapy twill be investigated measured through specific questionnaries at 3 months after surgery.
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

Geistlich Pharma AG

Investigators

  • Principal Investigator: Elena Calciolari, DDS, MS, PhD, QMUL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 339479

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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