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| Name | Class |
|---|---|
| Regedent AG, Zürich | UNKNOWN |
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The aim of this study is to compare the effectiveness in periodontal regeneration of cross-linked hyaluronic acid at 1.8% (Hyadent BG®) with enamel matrix derivative (Emdogain®) in periodontal bone defects evaluating their clinical and radiographic variables.
A high molecular weight polysaccharide, hyaluronic acid, also known as hyaluronan or hyaluronate, has recently been studied as a promising mediator for periodontal regeneration. It has a significant role in mineralized and non-mineralized periodontal tissues for the functioning of its extracellular matrices. It has a multifunctional role in periodontics including the stimulation of cell migration, proliferation and differentiation and the acceleration of wound healing by stimulating angiogenesis. It is used in surgical procedures due to its osteoinductive potential. HA is a key element in soft periodontal tissues, the gingiva and periodontal ligament, and in hard tissue, such as alveolar bone and cementum. It has many structural and physiological functions within these tissues.
This research proposes two experimental groups to whom one of them will be applied cross-linked hyaluronic acid at 1.8% and another group with enamel matrix derivative, and a control group.
The investigator's hypothesis is that the hyaluronic acid shows potential for periodontal regeneration when evaluating its clinical and radiographic variables and when compared with the use of Enamel matrix derivative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML | Experimental |
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| Enamel Matrix Proteins | Active Comparator |
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| Scale and root planning | No Intervention | Control group: Just SCALE AND ROOT PLANING is performed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML | Drug | Regenerative periodontal therapy + Cross-linked hyaluronic acid 1.8%:
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical measure: Clinical attachment loss (CAL). Changes will be assessed at 3 time points. | It is defined as the distance in millimeters between CEJ and the end of the periodontal pocket. The calculation of the depth of the pocket + gingival recession or pocket depth - gingival hyperplasia will be carried out. | 1. Baseline, 2. Reevaluation (60 days after root debridement), 3. Second reevaluation (180 days after Periodontal regenerative surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic measure: Cemento-enamel junction (A1) | • The cemento-enamel junction (CEJ)of the tooth involved in the intrabony defect. | 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery). |
| Radiographic measure: B1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrés López Roldán | University of Valencia | Study Director |
| Manuel Rodríguez Aranda | University of Valencia | Principal Investigator |
| Francisco Alpiste Illueca | University of Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Valencia | Valencia | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40106008 | Derived | Rodriguez-A M, Montiel-Company JM, Alpiste-Illueca F, Rodriguez-A L, Paredes-Gallardo V, Lopez-Roldan A. Comparision of crosslinked hyaluronic acid vs. enamel matrix derivative for periodontal regeneration: an 18-month follow-up randomized clinical trial. Clin Oral Investig. 2025 Mar 19;29(4):197. doi: 10.1007/s00784-025-06278-5. |
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Double-blinding: The researchers who performed the measurements will be different from those who performed the surgery; therefore, the examiner will be blinded during the entire duration of the study.
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| Enamel Matrix Proteins (Active comparator group) | Drug | Regenerative periodontal therapy + Enamel matrix proteins:
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The most coronal position of the alveolar bone crest of the intrabony defect when it touches the root surface of the adjacent tooth before treatment (the top of the crest).
| 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery). |
| Radiographic measure: D1 | The most apical extension of the intrabony destruction where the periodontal ligament space still retained its normal width before treatment (the bottom of the defect). | 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery). |
| Clinical measure: Probing pocket depth (PPD). Changes will be assessed at 3 time points. | The probing depth will be measured in six areas (disto-buccal, mediate-vestibular, mesio-buccal, disto-palatal, mid-palatal, and mesio-palatal) of each tooth with a Williams PQ-OW 208 396 probe. It will be use with a pressure of 20 grams that is equivalent to the pressure of dropping the weight of the probe without exerting additional pressure. | 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery). |
| Clinical measure: Gingival recession (GR). Changes will be assessed at 3 time points. | The "Full mouth bleeding score" (FMBS) will be calculated based on scores of 0 (no bleeding) or 1 (bleeding) after probing depths are checked. The usual thing is to measure 4 points for each tooth, but we have modified the index and we value 6 points per tooth (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio-palatal). We consider that the score is 1 when we see a red dot in the% bleeding diagram of the periodontogram and 0 when we see the blank box. | 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery). |
| Clinical measure: Tooth mobility (TM) Miller (1950). Changes will be assessed at 3 time points. |
| 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery). |
| Clinical measure: Furcation involvement: Hamp (1975). Changes will be assessed at 3 time points. | The plaque will be quantified as follows:
The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal). | 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery). |
| Clinical measure: Plaque Index (Sillness y Löe 1964). Changes will be assessed at 3 time points. | The plaque will be quantified as follows:
The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal). | 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery). |
| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D016301 | Alveolar Bone Loss |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| C109069 | enamel matrix proteins |
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