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

Not Applicable

Recruiting

• Conditions: Deep Margin Elevation; Pulpal and Periodontal Health

• Registration Number: NCT07169305
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

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.

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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-05-01
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Primary Completion: 2026-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• 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%

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Periodontal Parameters	Baseline to 12 months	Probing Depth

Secondary Outcome Measures

Name	Time	Method
Periodontal parameters and restoration quality	Baseline to 12 months	CAL, Plaque Index, Gingival Index. United States Public Health Service (USPHS) criteria for restoration quality

Trial Locations

Locations (1)

PGIDS; 🇮🇳 Rohtak, Haryana, India