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

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?

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Procedure: Deep Margin Elevation using resin composite; Procedure: Surgical Crown Lengthening

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep Margin Elevation	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.; Procedure: 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
Experimental: Surgical Crown Lengthtening	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.; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: 19750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No