Back to resultsDeep Margin Elevation Vs Crown Lengthening
Primary Purpose
Endodontically Treated Teeth
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Deep Margin Elevation using resin composite
Surgical Crown Lengthening
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth
Eligibility Criteria
Inclusion Criteria:
- Patients underwent endodontic treatment in the posterior region
- 18-40 years
- Male and Females
- Medically free patients
- Patients with healthy periodontium
- Patients with thick biotype.
- Patients having proximal margins violating the biological width
Exclusion Criteria:
- 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
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Deep Margin Elevation
Surgical Crown Lengthtening
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05381298
Brief Title
Deep Margin Elevation Vs Crown Lengthening
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
May 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Margin Elevation
Arm Type
Experimental
Arm Title
Surgical Crown Lengthtening
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Deep Margin Elevation using resin composite
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical Crown Lengthening
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Attachment Level
Description
the clinical attachment level will be measured from restoration margin to the base of the clinical gingival sulcus according to Günay et al
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients underwent endodontic treatment in the posterior region
18-40 years
Male and Females
Medically free patients
Patients with healthy periodontium
Patients with thick biotype.
Patients having proximal margins violating the biological width
Exclusion Criteria:
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
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Deep Margin Elevation Vs Crown Lengthening
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