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

Recruiting now · Not applicable

Conditions studied: Deep Margin Elevation, Pulpal and Periodontal Health

In brief

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.

Key facts

Study ID

NCT07169305

Run by

Postgraduate Institute of Dental Sciences Rohtak

People needed

81

Starts

2025-05-01

Expected to finish

2027-05-01

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• PGIDS — Rohtak, Haryana, India (enrolling)

Full record on ClinicalTrials.gov

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