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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04376450

Enrollment

Registered

2020-05-06

Start date

2019-03-06

Completion date

2020-12-31

Last updated

2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reconstructive Surgical Procedure

Keywords

Periodontitis; reconstructive surgical procedure;, guided tissue regeneration;, surgical flaps;treatment outcome

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.

Interventions

PROCEDUREExperimental- 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.

PROCEDUREActive 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

a randomized, triple-blinded, parallel study

Intervention model description

GROUP A: NONINCISED PAPILLAE SURGICAL APPROACH (NIPSA) GROUP B: ENTIRE PAPILLA PRESERVATION TECHNIQUE (EPP)

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

India

Contacts

Primary ContactR V Chandra, MDS;DNB;PhD

viswachandra@hotmail.com9908183071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026