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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05381298
Other study ID # 19750
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2020
Est. completion date May 5, 2022

Study information

Verified date May 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 5, 2022
Est. primary completion date December 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Deep Margin Elevation using resin composite
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.
Surgical Crown Lengthening
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

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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