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The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft.
Various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. The drawback of these techniques is the post-surgical gingival recession.
In order to overcome this drawback, the "entire papilla preservation" technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. Recently a novel surgical procedure, termed nonincised papillae surgical approach (NIPSA), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. This would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonincised Papillae Surgical Approach | Experimental | Nonincised papillae surgical approach is a papillae preservation technique, where an apical approach is carried out, without incisions or disinsertion of tissues at the level of the papillae or marginal tissues. |
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| Entire Papilla Preservation Technique | Active Comparator | Entire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental- Nonincised papillae surgical approach | Procedure | The basic principle of the technique is the placement of only one buccal horizontal or oblique incision in the mucosa, as apically as possible from the periodontal defect and the marginal tissues, and the raising of a mucoperiosteal flap coronally, which permits apical access to the defect but leaving the marginal tissues intact, acting as a "dome" for the protection of the clot. |
| Measure | Description | Time Frame |
|---|---|---|
| CLINICAL ATTACHMENT LEVEL (CAL) | measured from the cemento-enamel junction (CEJ) to the bottom of the pocket | Baseline to 6 months |
| POCKET PROBING DEPTH (PPD) | from the gingival margin to the bottom of the pocket; | Baseline to 6 months |
| Intrabony component (INTRA) of the defect | the distance from the most coronal extension of the interdental bone crest (BC) to the bottom of the defect (BD) (BC-BD). | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Papilla loss (PL) | measured from contact point to tip of the papilla. | Baseline to 6 months |
| Local bleeding score | recorded as positive when bleeding on probing was present at the surgical site. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| R V Chandra, MDS;DNB;PhD | Contact | 9908183071 | viswachandra@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| R V Chandra | Recruiting | Hyderabad | Telangana | 509002 | India |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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GROUP A: NONINCISED PAPILLAE SURGICAL APPROACH (NIPSA) GROUP B: ENTIRE PAPILLA PRESERVATION TECHNIQUE (EPP)
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a randomized, triple-blinded, parallel study
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| Active comparator- Entire papilla preservation technique | Procedure | The entire Papilla Preservation Technique is to preserve the whole integrity of the defect- associated papilla providing a tunnel-like undermining incision. The completely preserved interdental papilla provides an intact gingival chamber to stabilize the blood clot and improve the wound healing process. To provide adequate access for debridement, EPP requires a short buccal vertical releasing incision on the buccal side of the neighboring tooth extending just beyond the mucogingival line. |
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| Baseline to 6 months |