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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) |
|
| Control | Active Comparator | Periodontal Access Flap (AF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | Before and straight after completing the surgery, as well as at day 1, 4, 7, 15 and at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
If defect presents with an intrabony component, this should be ≤2 mm.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miljana Bacevic | Contact | +442078823063 | BHNT.Clinicaloralresearchcentre@nhs.net | |
| Elena Calciolari, DDS, MS, PhD | Contact | +442078823063 | e.calciolari@qmul.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Elena Calciolari, DDS, MS, PhD | QMUL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust Dental Hospital | Recruiting | London | E1 1BB | United Kingdom |
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| Periodontal Access Flap (AF) | 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 |
|
| 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). | 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). | Baseline and 3 months post-surgery |
| Clinical attachment level (CAL) | CAL will be calculated considering the values for PPD and REC in mm | 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). | 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 | 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. | 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). | 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). | Baseline and 3 months post-surgery |
| Early Healing Index (EHI) | The surgical wound will be graded as follows:
| 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. | 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. | 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. | 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. | 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. | 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. | 3 months after surgery |
| Centre for Oral Clinical Research (COCR) | Recruiting | London | E1 2AD | United Kingdom |
|
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010514 | Periodontal Pocket |
| D017622 | Periodontal Attachment Loss |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010518 | Periodontitis |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D011089 | Polydeoxyribonucleotides |
| ID | Term |
|---|---|
| D011119 | Polynucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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