Nonincised Papillae in the Treatment of Intrabony Defects.

NCT ID: NCT04376450

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2020-12-31

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.

Detailed Description

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.

Conditions

Reconstructive Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nonincised Papillae Surgical Approach

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.

Group Type: EXPERIMENTAL

Experimental- Nonincised papillae surgical approach

Intervention Type: 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.

Entire Papilla Preservation Technique

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

Group Type: ACTIVE_COMPARATOR

Active comparator- Entire papilla preservation technique

Intervention Type: 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.

Interventions

Experimental- Nonincised papillae surgical approach

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.

Intervention Type: PROCEDURE

Active comparator- Entire papilla preservation technique

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.

Intervention Type: PROCEDURE

Other Intervention Names

NIPSA; EPP

Eligibility Criteria

Inclusion Criteria

1. Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease.

2. Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm.

3. Adequate attached gingiva of 3mm and vestibular depth of 8mm. -

Exclusion Criteria

1. Uncontrolled systemic disease.

2. Pregnancy and lactation.

3. Defects involving lingual sites.

4. Presence of restoration in the experimental teeth.

5. Smokers -

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SVS Institute of Dental Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr R Viswa Chandra

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

R V Chandra

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

R V Chandra, MDS;DNB;PhD

Role: CONTACT

viswachandra@hotmail.com

9908183071

Facility Contacts

R V Chandra, MDS;DNB;PhD

Role: primary

viswachandra@hotmail.com

9908183071

Other Identifiers

SVSIDS/PERIO/2/2018

Identifier Type: -

Identifier Source: org_study_id