Deep margin elevation effects on tooth pulp and gum health at different gingival margin heights

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-randomized controlled trial will perform deep margin elevation (DME) with composite restorations on adult posterior teeth that have Class II cavities extending below the gumline. Patients will be grouped by gingival margin position placed ≥3 mm, 2–<3 mm, or 1–<2 mm above the alveolar crest, and restorations will be rated using USPHS clinical performance criteria. Outcomes include pulpal health (sensibility testing and symptoms), periodontal parameters (probing depth, clinical attachment level, gingival index, plaque index), and restoration quality. The comparison across margin levels aims to determine whether limited subgingival placement via DME is tolerated without resorting to surgical crown lengthening.

Why it matters

Who can join: the full rules

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

Where it's running

• Pgids
  Rohtak, Haryana, India Recruiting

Study contacts

• Principal investigator: Dr. Mayank Arora, MDS — PGIDS, Rohtak
• Study coordinator: Dr. Mayank Arora
• Email: drarora002@gmail.com
• Phone: 8295964200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.