Nonincised Papillae in the Treatment of Intrabony Defects.

Not Applicable

• Conditions: Reconstructive Surgical Procedure
• Interventions: Procedure: Experimental- Nonincised papillae surgical approach; Procedure: Active comparator- Entire papilla preservation technique

• Registration Number: NCT04376450
• Lead Sponsor: SVS Institute of Dental Sciences

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.

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-02
• Last Update Submitted: 2020-05-02
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonincised Papillae Surgical Approach	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.
Entire Papilla Preservation Technique	Active comparator- Entire papilla preservation technique	Entire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla

Primary Outcome Measures

Name	Time	Method
CLINICAL ATTACHMENT LEVEL (CAL)	Baseline to 6 months	measured from the cemento-enamel junction (CEJ) to the bottom of the pocket
POCKET PROBING DEPTH (PPD)	Baseline to 6 months	from the gingival margin to the bottom of the pocket;
Intrabony component (INTRA) of the defect	Baseline to 6 months	the distance from the most coronal extension of the interdental bone crest (BC) to the bottom of the defect (BD) (BC-BD).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

R V Chandra; 🇮🇳 Hyderabad, Telangana, India