An interventional study of Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) and Periodontal Access Flap (AF) in Periodontal Diseases, Wound Heal and Periodontal Inflammation, sponsored by Queen Mary University of London. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Queen Mary University of London · Not applicable, Interventional, and Treatment
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.
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.
867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 24 is below the median of 45 across 557 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Queen Mary University of London is the lead sponsor of 253 studies on the registry; 58 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If defect presents with an intrabony component, this should be ≤2 mm.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Periodontal Access Flap (AF)
Procedure: Periodontal Access Flap (AF)
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
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
Early wound healing molecular events through GCF
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.
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
Blood flow changes in the surgical area will be evaluated with Laser Speckle Contrast Imaging (LSCI)
Time frame: Before and straight after completing the surgery, as well as at day 1, 4, 7, 15 and at 3 months
Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the 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.
Time frame: Baseline and 3 months post-surgery
Probing pocket depth (PPD)
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).
Time frame: Baseline and 3 months post-surgery
Gingival recession (REC)
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).
Time frame: Baseline and 3 months post-surgery
Clinical attachment level (CAL)
CAL will be calculated considering the values for PPD and REC in mm
Time frame: Baseline and 3 months post-surgery
Suppuration
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).
Time frame: Baseline and 3 months post-surgery
Gingival phenotype
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
Time frame: Baseline and 3 months post-surgery
Keratinized tissue (KT)
Keratinized tissue width will be assessed in mm with a periodontal probe measuring from the mucogingival junction to the free gingival margin.
Time frame: Baseline and 3 months post-surgery
Full mouth plaque score (FMPS)
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).
Time frame: Baseline and 3 months post-surgery
Full mouth bleeding score (FMBS)
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).
Time frame: Baseline and 3 months post-surgery
Early Healing Index (EHI)
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.
Time frame: Day 1, 4, 7 and 15 after the surgical intervention
Gingival morphometric changes
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.
Time frame: Baseline visit, at 1, 4, 7, 15 days and 3 months post surgery
Oral impact on daily performance (OIDP)
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.
Time frame: Baseline and at 3 months post surgery
Dentine/root sensitivity
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.
Time frame: Baseline and at 3 months post-surgery
Food impaction
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.
Time frame: Baseline and at 3 months post-surgery
Patient perception about 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.
Time frame: At day 1, 4, 7 and 15 after surgical therapy
Global ratings of Periodontal Health and Quality of Life
Periodontal health and quality of life following periodontal therapy twill be investigated measured through specific questionnaries at 3 months after surgery.
Time frame: 3 months after surgery
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