Gingival Margin Stability Following Esthetic Crown Lengthening Utilizing a Double Periodontal Surgical Guide

May 1, 2024 updated by: Doaa Adel Salah Khattab, Ain Shams University

Gingival Margin Stability Following Esthetic Crown Lengthening by Electrocautery, Diode Laser, or a Scalpel Blade Utilizing a Double Periodontal Surgical Guide. (A Prospective Randomized Clinical Trial)

In patients with excessive gingival display, esthetic crown lengthening procedure by means of scalpel, diode laser or electro-surgery could result in the same gingival marginal stability at 3 and 6 months follow up.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Scalpel crown lengthening has been recommended as the gold standard for treating excessive gingiva. Two other established tools used for gingivectomy procedures are electrosurgery and lasers. Laser crown lengthening may have the advantages of less bleeding during the procedure, faster healing, and less pain following the procedure. Electrosurgery which involves the application of a high- frequency electric current to the gingiva has been shown to produce minimal bleeding, ease and speed of cutting and reduced postoperative pain. The null hypothesis that the three techniques for aesthetic crown lengthening (ACLP) would show equivalent gingival margin stability at 3 and 6 months follow up.

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Abbassia
      • Cairo, Abbassia, Egypt, 11566
        • Doaa Adel Salah Khattab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Altered passive eruption as presence of quadratic anterior teeth [crown width/length ratio

    • 0.85 ].
  • Gingival margin located coronal to the tooth cervical convexity and >2 mm of gingival band display during maximum smile.
  • Patients with treated periodontal disease (i.e., stage I of periodontitis);

Exclusion Criteria:

  • Patients with systemic contraindications for oral surgery as uncontrolled diabetes.
  • patients on drug therapy related with drug-associated gingival enlargement.
  • Areas in which the remaining amount of keratinized gingiva after the submarginal incision is less than 3 mm.
  • Previous surgical treatment in the same area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scalpel crown lengthening
Crown lengthening will be performed utilizing double periodontal surgical guide with scalpel.
Procedure: Crown lengthening
Investigation of the three techniques for aesthetic crown lengthening
Experimental: Laser crown lengthening
Crown lengthening will be performed utilizing double periodontal surgical guide with diode laser.
Procedure: Crown lengthening
Investigation of the three techniques for aesthetic crown lengthening
Experimental: Electrosurgery crown lengthening
Crown lengthening will be performed utilizing double periodontal surgical guide with electrosurgery.
Procedure: Crown lengthening
Investigation of the three techniques for aesthetic crown lengthening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
position of the gingival margin
Time Frame: 3 and 6 months postoperative
position of the gingival margin (GM) (Degree of Gingival Rebound) after performing an aesthetic crown lengthening procedure
3 and 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Doaa Adel-Khattab, PhD, Associate Professor Faculty of Dentistry, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2024

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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