Fully Digital Guided Esthetic Crown Lengthening Surgery

February 24, 2025 updated by: Abdallah Abdelnabi, Ain Shams University

Fully Digital Guided Esthetic Crown Lengthening Surgery: Evaluation of Accuracy and Patient Satisfaction (A Randomized Controlled Clinical Study)

The goal of this randomized controlled clinical study is to compare Fully digital to wax-up/mock-up guided esthetic crown lengthening procedure in management of excessive gingival display caused by altered passive eruption type 1B

The main question it aims to answer is:

Does the fully digital guided gingivectomy approach able to introduce a more precise, accuracy and reliability technique with more patient satisfaction compared to the mock-up guided method?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In today's world, the idea of smile and dental aesthetics extends beyond just the teeth. The fundamentals of a smile center on the interaction between the three key elements: the teeth, lips , and the gingiva.

Gummy smile (Excessive gingival display) is acknowledged by the American Academy of Periodontology (AAP) as a deformity and mucogingival problem that impacts the area surrounding the teeth

This condition may result from various etiological factors: short lip, hypermobile/hyperactive lip, short clinical crowns, dentoalveolar extrusion, altered passive eruption (APE), gingival hyperplasia, and vertical maxillary excess.

Altered passive eruption is described as "the gingival margin in adults is positioned incisal to the crown's cervical convexity and distanced from the tooth's cementoenamel junction."

Altered passive eruption defined as "the gingival margin in the adult is located incisal to the cervical convexity of the crown and removed from the cementoenamel junction of the tooth".

Altered passive eruption classified into two main classes according to the relationship of the gingiva to the anatomic crown and furthermore subdivided those classes according to the position of the osseous crest. The two types are subdivided into four categories: 1A, 1B and 2A, 2B.

The diagnosis of APE is made on a collective clinical and radiographic examination, it begins with analyzing the repose during a natural smile followed by analyzing the gingival display, the alveolar crest level, as well as the lip line of the patient.

Determination can be made whether a gingivectomy alone will suffice or a gingival flap will be needed with or without ostectomy will depend of the diagnosis of APE and classification of each case.

The selection of one technique over another depends on several patient related factors such as esthetics, clinical crown to root ratio, root proximity, root morphology, furcation location, individual tooth position, collective tooth position and ability to restore the teeth.

Esthetic crown lengthening (ECL) approach (both gingivectomy and bone removal) is used when less than 2 mm exists between the crest of the bone and the new gingival margin, and an adequate attached gingiva will remain after surgery (APE type IB).

Diagnostic mock-up fabricated using a temporary bis-acrylic resin with a putty guide directly from the wax-up can be used to provide the patient and clinician with an evaluation of the future outcome and can be used as a surgical guide for crown lengthening procedures.

The major limitations with wax-up/ mock-up guided esthetic crown lengthening procedure would be the time consumed during making and modifying conventional wax-ups as well as the unpredictable estimate of where the gingival margin should be.

Utilization of digital workflows allowed the enhancement of communication and might improve the predictability of contemporary ECL approach.

The introduction of computer-aided design and computer-aided manufacturing (CAD-CAM) techniques has helped surgeons perform more precise and predictable surgery and contributed to improved esthetics.

By combining the use of Digital Smile Design and CAD/CAM technology with (3D) printing, a surgical guide for ECL procedure could be produced.

The aim of the present study will be to evaluate accuracy and reliability of digital guided method of ECL procedure using CAD CAM technology versus conventional method using resin Mock-up as ECL surgical guide.

Study Type

Interventional

Enrollment (Estimated)

18

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 Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Faculty of Dentistry - Ain Shams University

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:

  • Patients who have Altered passive eruption (APE) type 1 B, according to classification of APE by Coslet et al.

Both genders aged from 20-50 years. Patients have thick gingival phenotype (thickness of gingiva is ≥ 1 mm) Patients should be systematically free from any disease.

Exclusion Criteria:

  • Pregnant and lactating females.
  • Heavy smoker ≥ 10 cigarettes/day.
  • Poor oral hygiene.
  • Patients with occlusal or malalignment problems.

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
Active Comparator: Conventional arm
Esthetic crown lengthening surgery is done using mock-up based guide
Procedure: Esthetic crown lengthening surgery
Esthetic crown lengthening surgery using mock-up based guide
Active Comparator: Digital arm
Esthetic crown lengthening surgery is done using digital guide
Procedure: Esthetic crown lengthening surgery using Digital guide
Esthetic crown lengthening surgery using digital guide based on DSD and CBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of both guides
Time Frame: Immediately after the surgery
The accuracy can be measured by comparing the planned surgery and the actual result of the surgery Linear measurement in millimeters
Immediately after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 3 months after the surgery
This can be measured using a questionnaire includes questions about patient expectations about the surgery, pain during and after the surgery, and the overall results
3 months after the surgery
Marginal stability
Time Frame: 4 weeks and 3 months
Gingival margin is been evaluated after 4 weeks and 3 months of the surgery using subsequent intraoral scanning Linear measurement in millimeters
4 weeks and 3 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Ahmed E Amr, Ass.Prof, Faculty of Dentistry - Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 20, 2025

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

May 20, 2025

Study Registration Dates

First Submitted

January 25, 2025

First Submitted That Met QC Criteria

January 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-ReclM122210

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Gummy Smile

Clinical Trials on Esthetic crown lengthening surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe