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Recruiting NCT07169305

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

Trial Parameters

Condition Deep Margin Elevation
Sponsor Postgraduate Institute of Dental Sciences Rohtak
Study Type INTERVENTIONAL
Phase N/A
Enrollment 81
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-01
Completion 2026-05-01
Interventions
Deep Margin Elevation

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.

Eligibility Criteria

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

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