Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT07169305
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07169305
Study Brief:
Protocol Section:
NCT07169305