Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07169305
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Study Overview
Official Title:
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level in Class II Subgingival Composite Restorations
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Rationale: Deep margin Elevation is a technique used in restorative dentistry which helps in dealing with deep Subgingival margins. The placement of gingival seat in relation to crestal bone significantly influences pulpal and periodontal health. Biologic width is essential for maintaining healthy periodontal tissues, but the effect of limited violations needs to be evaluated. Less invasive procedures like DME are preferable alternative to surgical crown lengthening. Aims \& Objectives: 1.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above alveolar crest on pulpal health 2.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above alveolar crest on gingival health 3.To evaluate and compare the effect of DME performed in Class II at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above alveolar crest on restoration quality.
Population - Adult patients with class II cavities at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above the alveolar crest. Intervention - DME performed in Class II cavities at 2mm to \<1mm and 1mm to \<2mm above the alveolar crest with composite. Comparator- DME performed in Class II cavities at ≥3mm above the alveolar crest with Composite. Outcome- Clinical performance according to USPHS criteria, Periodontal parameters i.e. Probing depth and CAL, Gingival Index and Plaque Index.
Population - Adult patients with class II cavities at ≥3mm, 2mm to \<3mm, 1mm to \<2mm above the alveolar crest. Intervention - DME performed in Class II cavities at 2mm to \<1mm and 1mm to \<2mm above the alveolar crest with composite. Comparator- DME performed in Class II cavities at ≥3mm above the alveolar crest with Composite. Outcome- Clinical performance according to USPHS criteria, Periodontal parameters i.e. Probing depth and CAL, Gingival Index and Plaque Index.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: