NCT07169305

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Rationale: Deep margin Elevation is a technique used in restorative dentistry which helps in dealing with deep Subgingival margins. The placement of gingival seat in relation to crestal bone significantly influences pulpal and periodontal health. Biologic width is essential for maintaining healthy periodontal tissues, but the effect of limited violations needs to be evaluated. Less invasive procedures like DME are preferable alternative to surgical crown lengthening. Aims \& Objectives: 1.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above alveolar crest on pulpal health 2.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above alveolar crest on gingival health 3.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above alveolar crest on restoration quality. Population - Adult patients with class II cavities at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above the alveolar crest. Intervention - DME performed in Class II cavities at 2mm to \<1mm and 1mm to \<2mm above the alveolar crest with composite. Comparator- DME performed in Class II cavities at ≥3mm above the alveolar crest with Composite. Outcome- Clinical performance according to USPHS criteria, Periodontal parameters i.e. Probing depth and CAL, Gingival Index and Plaque Index.

Conditions

• Deep Margin Elevation
• Pulpal and Periodontal Health

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: India