Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPostgraduate Institute of Dental Sciences Rohtak
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Deep Margin Elevation
Procedure/SurgeryThe tooth preparation is performed using conventional diamond burs. The extent of caries decides the group into which the participant falls. A precontoured sectional matrix (Palodent) with a properly sized plastic diamond wedge (Bioclear Matrix Systems) is applied and stabilized using a separating ring to ensure closure of deep cervical margins, adaptation of the matrix cervically and attain contact tightness. A 37% phosphoric acid etch gel is used for Selective Enamel Etching technique for 15-20 seconds. Two coats of adhesive are applied to both enamel and dentin using a microbrush and light cured. Flowable bulkfill composite (SDR plus, Dentsply, Sirona) restorative composite is placed using teflon coated hand instruments to perform DME till the level of CEJ and light cured for 20s. Further build up of proximal box is done using packable composite. The restoration is finished using fine grit yellow coded tapered diamond stones. Polishing done by using Composite Polishing kits.
Treatment groups
81 Participants
are divided into 3 treatment groupsGroup A: Class II cavities 2mm to <3mm above the alveolar crestExperimental treatment 1 intervention
Group B: Class II cavities 1mm to <2mm above the alveolar crestExperimental treatment 1 intervention
Group C: Class II cavities ≥3mm above the alveolar crestActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Periodontal Parameters
Probing Depth
Time frame
Baseline to 12 monthsSecondary outcomes
1
Periodontal parameters and restoration quality
CAL, Plaque Index, Gingival Index. United States Public Health Service (USPHS) criteria for restoration quality
Time frame
Baseline to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov