Deep Margin Elevation Vs Crown Lengthening
Biological Evaluation of Indirect Restorations in Endodontically-treated Posterior Teeth With Deeply Located Proximal Margins Following Deep Margin Elevation Versus Surgical Crown Lengthening: A Randomized Controlled Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
The present clinical trial will be conducted to reject or accept the null hypothesis that in endodontically treated posterior teeth with deeply located proximal margins, will the Deep Margin Elevation will have better results from surgical crown lengthening in terms of biological criteria?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2022
CompletedFirst Submitted
Initial submission to the registry
May 12, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedMay 19, 2022
May 1, 2022
1.3 years
May 12, 2022
May 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Attachment Level
the clinical attachment level will be measured from restoration margin to the base of the clinical gingival sulcus according to Günay et al
12 month
Study Arms (2)
Deep Margin Elevation
EXPERIMENTALSurgical Crown Lengthtening
EXPERIMENTALInterventions
After completion of the root canal treatment of the offended tooth and comprehensive evaluation of the obtained treatment, the randomly allocated patients will undergo deep margin elevation procedure where rubber dam isolation will be accomplished Followed by proper matricing and wedging ) followed by selective enamel etching for 10 seconds then universal adhesive application following the manufacturer instructions followed by application of flowable resin composite for the first 1 mm and light cured for 20 seconds according to the manufacturer recommendations followed by application of packable bulk fill composite to elevate the margins and light cured following the manufacturer instructions.
Participants in this group will undergo surgical crown lengthening in which an internal bevel incision will be done buccally and lingually followed by full thickness flap reflection using mucoperiosteal elevator, then interproximal bone removal will be done using end cutting bur to the planned position away from the margins by 3 mm. The flap will be displaced apically with apically positioned sutures. Postoperative instructions will be given to the patient aiming to control postsurgical complications including pain and swelling. Suture removal and assessment of the surgical site will be done after two weeks
Eligibility Criteria
You may qualify if:
- Patients underwent endodontic treatment in the posterior region
- years
- Male and Females
- Medically free patients
- Patients with healthy periodontium
- Patients with thick biotype.
- Patients having proximal margins violating the biological width
You may not qualify if:
- Patients with chronic periodontal disease.
- Patients with persistent poor oral hygiene.
- Patients with unsuccessful root canal treatment.
- Periapical Abscess or Fistula.
- Patients with proximal margins beyond the bone level.
- Patients with developmental dental anomalies.
- Patients undergoing or will start orthodontic treatment
- Patients with removable prosthesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle Investigator
Study Record Dates
First Submitted
May 12, 2022
First Posted
May 19, 2022
Study Start
September 2, 2020
Primary Completion
December 15, 2021
Study Completion
May 5, 2022
Last Updated
May 19, 2022
Record last verified: 2022-05