Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft

Universidad de Murcia24 enrolled

Overview

This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Periodontitis Periodontal Diseases Periodontal Pocket Periodontal Attachment Loss

Interventions

Non-incised papila surgical approach without grafting biomaterialPROCEDURE

Periodontal reconstructive surgery

Non-incised papila surgical approach with grafting biomaterialPROCEDURE

Periodontal reconstructive surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. * 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.

Locations (1)

Centro Odontologico Del Sureste Slp

Murcia, Spain

Outcomes

Primary Outcomes

Probing pocket depth (PD)

Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket

Time frame: 12 months

Clinical attachment level (CAL)

Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.

Time frame: 12 months

Recession (REC)

Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.

Time frame: 12 months

Location of the tip of the papillae (TP)

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.

Time frame: 12 months

Keratinized tissue width (KT)

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.

Time frame: 12 months

Bleeding on probing

Bleeding on probing could be positive or negative.

Time frame: 12 months

Secondary Outcomes

Supra-alveolar attachment gain (SUPRA-AG)

Data from ClinicalTrials.gov

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