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Nonincised Papillae in the Treatment of Intrabony Defects.

S

SVS Institute of Dental Sciences

Status

Unknown

Conditions

Reconstructive Surgical Procedure

Treatments

Procedure: Active comparator- Entire papilla preservation technique
Procedure: Experimental- Nonincised papillae surgical approach

Study type

Interventional

Funder types

Other

Identifiers

NCT04376450
SVSIDS/PERIO/2/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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 -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

34 participants in 2 patient groups

Nonincised Papillae Surgical Approach
Experimental group
Description:
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.
Treatment:
Procedure: Experimental- Nonincised papillae surgical approach
Entire Papilla Preservation Technique
Active Comparator group
Description:
Entire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla
Treatment:
Procedure: Active comparator- Entire papilla preservation technique

Trial contacts and locations

1

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Central trial contact

R V Chandra, MDS;DNB;PhD

Data sourced from clinicaltrials.gov

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