Deep margin elevation effects on tooth pulp and gum health at different gingival margin heights
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level in Class II Subgingival Composite Restorations
This trial will try deep margin elevation with composite restorations at different heights near the gum to see if adults with subgingival Class II cavities keep healthy tooth pulp and gums.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Trial ID | NCT07169305 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with permanent posterior teeth and Class II subgingival caries who have at least 1 mm of sound tooth structure from the alveolar crest to the cavity base, are periodontally healthy, and have asymptomatic or reversible pulpitis are ideal candidates.
Not a fit: Patients with irreversible pulpitis, active periodontal disease, insufficient remaining tooth structure, systemic bone disorders, or exclusions such as pregnancy, smoking, heavy alcohol use, or recent anti-inflammatory drug use are unlikely to benefit.
Why it matters
Potential benefit: If successful, DME could offer a less invasive alternative to surgical crown lengthening for restoring deep proximal lesions while preserving pulp and periodontal health.
How similar studies have performed: Existing evidence is limited to case reports and small series suggesting periodontal tolerance of limited subgingival margins, but there are few adequately powered clinical trials validating the approach.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Rohtak, Haryana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.