Nonincised Papillae in the Treatment of Intrabony Defects.

Reconstructive Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376450
• Other study ID #: SVSIDS/PERIO/2/2018
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: SVS Institute of Dental Sciences
• Contact: R V Chandra, MDS;DNB;PhD
• Phone: 9908183071
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Reconstructive Surgical Procedure

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	R V Chandra	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CLINICAL ATTACHMENT LEVEL (CAL)	measured from the cemento-enamel junction (CEJ) to the bottom of the pocket	Baseline to 6 months
Primary	POCKET PROBING DEPTH (PPD)	from the gingival margin to the bottom of the pocket;	Baseline to 6 months
Primary	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	Papilla loss (PL)	measured from contact point to tip of the papilla.	Baseline to 6 months
Secondary	Local bleeding score	recorded as positive when bleeding on probing was present at the surgical site.	Baseline to 6 months