Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level (NCT07169305) | Clinical Trial Compass
RecruitingNot Applicable
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
India81 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Periodontal Parameters
Timeframe: Baseline to 12 months
Trial details
NCT IDNCT07169305
SponsorPostgraduate Institute of Dental Sciences Rohtak