Deep Margin Elevation Vs Crown Lengthening

Endodontically Treated Teeth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381298
• Other study ID #: 19750
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

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