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OpenTrials
Completed

NCT Number: NCT05381298

Deep Margin Elevation Vs Crown Lengthening

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?

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Margin Elevation using resin composite

Procedure

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

Procedure

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 outcomes

  1. Clinical Attachment Level

    Time frame: 12 month

    the clinical attachment level will be measured from restoration margin to the base of the clinical gingival sulcus according to Günay et al

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 19, 2022
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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