Nonincised Papillae in the Treatment of Intrabony Defects.

NCT04376450 | Unknown

• 1 other identifier: SVSIDS/PERIO/2/2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reconstructive Surgical Procedure

Keywords

Periodontitis; reconstructive surgical procedure;; guided tissue regeneration;; surgical flaps;treatment outcome

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Papilla loss (PL)

  Baseline to 6 months

• Local bleeding score

  Baseline to 6 months

Study Arms (2)

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.

Procedure: Experimental- Nonincised papillae surgical approach

Entire Papilla Preservation Technique

ACTIVE COMPARATOR

Entire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla

Procedure: Active comparator- Entire papilla preservation technique

Interventions

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.

Also known as: NIPSA

Nonincised Papillae Surgical Approach

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.

Also known as: EPP

Entire Papilla Preservation Technique

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease.
• Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm.
• Adequate attached gingiva of 3mm and vestibular depth of 8mm. -

You may not qualify if:

• Uncontrolled systemic disease.
• Pregnancy and lactation.
• Defects involving lingual sites.
• Presence of restoration in the experimental teeth.
• Smokers -

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

R V Chandra

Hyderabad, Telangana, 509002, India

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

R V Chandra, MDS;DNB;PhD

CONTACT

9908183071; viswachandra@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: a randomized, triple-blinded, parallel study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: GROUP A: NONINCISED PAPILLAE SURGICAL APPROACH (NIPSA) GROUP B: ENTIRE PAPILLA PRESERVATION TECHNIQUE (EPP)

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 6, 2020
• Study Start: March 6, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)