Status:
RECRUITING
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
Lead Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Conditions:
Deep Margin Elevation
Pulpal and Periodontal Health
Eligibility:
All Genders
18+ years
Phase:
NA
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 extens...
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 significa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT07169305
Start Date
May 1 2025
End Date
May 1 2027
Last Update
September 11 2025
Active Locations (1)
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1
PGIDS
Rohtak, Haryana, India, 124001