NCT07169305 Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
| NCT ID | NCT07169305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak |
| Condition | Deep Margin Elevation |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 81 participants in total. It began in 2025-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Dr. Mayank Arora, MDS
PRINCIPAL INVESTIGATOR
PGIDS, Rohtak
Frequently Asked Questions
Who can join the NCT07169305 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Deep Margin Elevation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07169305 currently recruiting?
Yes, NCT07169305 is actively recruiting participants. Contact the research team at drarora002@gmail.com for enrollment information.
Where is the NCT07169305 trial being conducted?
This trial is being conducted at Rohtak, India.
Who is sponsoring the NCT07169305 clinical trial?
NCT07169305 is sponsored by Postgraduate Institute of Dental Sciences Rohtak. The principal investigator is Dr. Mayank Arora, MDS at PGIDS, Rohtak. The trial plans to enroll 81 participants.