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New treatment option for Deep Margin Elevation
Official title Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
ClinicalTrials.gov ID: NCT07169305
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- Periodontally sound tooth
You likely can't join 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
See the full eligibility 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%
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rohtak, Haryana, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rohtak, Haryana, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.