Nonincised Papillae in the Treatment of Intrabony Defects.

A Comparative Evaluation of Nonincised Papillae and Entire Papilla Preservation Surgical Approach in the Treatment of Intrabony Defects - a Clinical and Radiographic Study

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.

Study Overview

• Status: Unknown
• Conditions: Reconstructive Surgical Procedure
• Intervention / Treatment: Procedure: Experimental- Nonincised papillae surgical approach; Procedure: Active comparator- Entire papilla preservation technique

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 509002
      • Recruiting
      • R V Chandra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 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.; Other Names: NIPSA
ACTIVE_COMPARATOR: Entire Papilla Preservation Technique; Entire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla	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.; Other Names: EPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Papilla loss (PL)	measured from contact point to tip of the papilla.	Baseline to 6 months
Local bleeding score	recorded as positive when bleeding on probing was present at the surgical site.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: SVS Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (ACTUAL): May 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Periodontitis; reconstructive surgical procedure;; guided tissue regeneration;; surgical flaps;treatment outcome
• Other Study ID Numbers: SVSIDS/PERIO/2/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No