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

NCT07169305 | Recruiting

• 1 other identifier: Swathi C
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deep Margin Elevation; Pulpal and Periodontal Health

Keywords

Deep margin elevation; Pulpal and Periodontal health; Class II Composite restorations

Outcome Measures

Primary Outcomes (1)

• Periodontal Parameters

  Probing Depth

  Baseline to 12 months

Secondary Outcomes (1)

• Periodontal parameters and restoration quality

  Baseline to 12 months

Study Arms (3)

Class II cavities 2mm to <3mm above the alveolar crest

EXPERIMENTAL

DME is performed in Class II cavities 2mm to \<3mm above the alveolar crest and restored with composite.

Procedure: Deep Margin Elevation

Class II cavities 1mm to <2mm above the alveolar crest

EXPERIMENTAL

DME is performed in Class II cavities 1mm to \<2mm above the alveolar crest and restored with composite.

Procedure: Deep Margin Elevation

Class II cavities ≥3mm above the alveolar crest

ACTIVE COMPARATOR

DME is performed in Class II cavities ≥3mm above the alveolar crest and restored with composite.

Procedure: Deep Margin Elevation

Interventions

Deep Margin Elevation PROCEDURE

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.

Class II cavities 1mm to <2mm above the alveolar crest; Class II cavities 2mm to <3mm above the alveolar crest; Class II cavities ≥3mm above the alveolar crest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years of age at the time of treatment.
• Permanent Posterior teeth exhibiting proximal caries lesion extending subgingivally below the cemento-enamel junction (CEJ). The axial extent of the caries should not be more than 75% of the dentin thickness.
• Sound tooth structure of atleast 1mm should be present from the alveolar crest to the base of the cavity/ gingival seat after cavity preparation.
• The tooth should either be asymptomatic or have reversible pulpitis as determined by history and pulp sensibility testing. There should be no history of spontaneous or lingering pain
• Periodontally sound tooth
• Full mouth plaque score (FMPS): ≤ 15% and Full mouth bleeding score (FMBS): ≤15%

You may not qualify if:

• Presence of bone disease (metabolic, endocrine, infectious, tumoral, developmental pathologies)
• Pregnant or lactating and history of smoking or alcohol abuse
• Anti inflammatory drug consumption within past 3 days
• Uncontrolled or poorly controlled diabetes
• Unstable Life threatening conditions or requiring antibiotic prophylaxis.
• Presence of detectable plaque and Bleeding on probing on the tooth to be treated
• Thin gingival biotype, Periodontitis and Gingival recession
• Class II cavities with gingival margin above the CEJ
• Previously restored teeth
• Absence of adjacent tooth or antagonist or Crown in adjacent tooth.
• H/o Bruxism, Xerostomia
• Requiring gingivectomy
• Isolation with rubber dam not possible

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• Dr. Mayank Arora, MDS

  PGIDS, Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mayank Arora

CONTACT

8295964200; drarora002@gmail.com

Dr. Swathi C

CONTACT

8618677427; swathic188@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: September 11, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-04

Locations

IN (1)