Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07169305
NA

Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level

Sponsor: Postgraduate Institute of Dental Sciences Rohtak

View on ClinicalTrials.gov

Summary

The classical idea was to keep the biologic width untouched in order to maintain periodontal health but the newer case reports have given a new dimension to this concept, stating that a limited extension into STA can be used as an alternative for invasive procedures like SCL. The periodontal tissues can still tolerate subgingival margin placement in biologic width when restorations are free of overhangs which are real culprit for providing room for plaque retention and further inflammation. There are no sufficient clinical studies with good sample size to prove the significance of this concept. Hence, we are performing a Non Randomized Controlled trial by placing gingival margins at various levels above the alveolar crest and restoring it with composite and further evaluate the periodontal tissue health, pulpal health, restoration quality and significance of DME.

Official title: Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level in Class II Subgingival Composite Restorations

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2025-05-01

Completion Date

2027-05-01

Last Updated

2025-09-11

Healthy Volunteers

Yes

Interventions

PROCEDURE

Deep Margin Elevation

The tooth preparation is performed using conventional diamond burs. The extent of caries decides the group into which the participant falls. A precontoured sectional matrix (Palodent) with a properly sized plastic diamond wedge (Bioclear Matrix Systems) is applied and stabilized using a separating ring to ensure closure of deep cervical margins, adaptation of the matrix cervically and attain contact tightness. A 37% phosphoric acid etch gel is used for Selective Enamel Etching technique for 15-20 seconds. Two coats of adhesive are applied to both enamel and dentin using a microbrush and light cured. Flowable bulkfill composite (SDR plus, Dentsply, Sirona) restorative composite is placed using teflon coated hand instruments to perform DME till the level of CEJ and light cured for 20s. Further build up of proximal box is done using packable composite. The restoration is finished using fine grit yellow coded tapered diamond stones. Polishing done by using Composite Polishing kits.

Locations (1)

PGIDS

Rohtak, Haryana, India