NIPSAGRAFT: Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
Study Details
Study Description
Brief Summary
This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NIPSA without grafting biomaterial A single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. |
Procedure: Non-incised papila surgical approach without grafting biomaterial
Periodontal reconstructive surgery
|
| Active Comparator: NIPSA with grafting biomaterial A single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied and the bone defect will be filled with a composite of xenograft and enamel matrix derivates. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. |
Procedure: Non-incised papila surgical approach with grafting biomaterial
Periodontal reconstructive surgery
|
Outcome Measures
Primary Outcome Measures
- Probing pocket depth (PD) [12 months]
Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket
- Clinical attachment level (CAL) [12 months]
Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.
- Recession (REC) [12 months]
Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
- Location of the tip of the papillae (TP) [12 months]
Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mm.
- Keratinized tissue width (KT) [12 months]
Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
- Bleeding on probing [12 months]
Bleeding on probing could be positive or negative.
Secondary Outcome Measures
- Supra-alveolar attachment gain (SUPRA-AG) [12 months]
Subtracting the 12-month CAL from the intra-surgically BC-CEJ will provide the SUPRA-AG result.
- Wound closure (WC) [1 week]
Complete wound closure (CWC = 2) Incomplete wound closure (IWC = 1) necrosis (NT = 0).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patients diagnosed with periodontitis.
-
plaque index and bleeding index of < 30%.
-
periodontal lesions with pocket probing depth > 5 mm.
-
intrabony defect > 3 mm.
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intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.
Exclusion Criteria:
-
patients with systemic diseases that contraindicated treatment.
-
third molars.
-
teeth with incorrect endodontic or restorative treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro Odontologico Del Sureste Slp | Murcia | Spain | 30007 |
Sponsors and Collaborators
- Universidad de Murcia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Moreno Rodriguez JA, Caffesse RG. Nonincised Papillae Surgical Approach (NIPSA) in Periodontal Regeneration: Preliminary Results of a Case Series. Int J Periodontics Restorative Dent. 2018;38(Suppl):s105-s111. doi: 10.11607/prd.3195.
- Moreno Rodríguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.
- Moreno Rodríguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
- 2441/2019