Comparison of Dual Digitally Guided vs Conventional Crown Lengthening (DIGICROWN)

May 4, 2026 updated by: Arab International University

Randomized Controlled Trial Evaluating Digital Dual Surgical Guide in Esthetic Crown Lengthening

This randomized controlled clinical trial aims to evaluate the clinical performance and patient-centered outcomes of dual digitally guided crown lengthening compared to the conventional surgical technique in the management of gummy smile caused by altered passive eruption (Type B1).

A total of 18 patients will be randomly allocated into two groups: the control group will undergo conventional crown lengthening based on clinical measurements, while the intervention group will receive crown lengthening using a dual digitally fabricated surgical guide.

The primary outcome is the gain in clinical crown length at 3 months. Secondary outcomes include operating time, pain perception, patient satisfaction, gingival margin stability, and periodontal clinical parameters.

This study aims to determine whether digital guidance improves surgical accuracy, efficiency, and patient satisfaction compared to traditional techniques

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Esthetic crown lengthening is a commonly performed periodontal surgical procedure indicated for the correction of excessive gingival display, particularly in cases of altered passive eruption. Achieving optimal esthetic outcomes requires precise determination of gingival and osseous resection levels, which can be challenging using conventional clinical methods.

With the advancement of digital dentistry, computer-aided design and manufacturing (CAD/CAM) technologies have enabled the development of digitally guided surgical approaches. The dual digitally guided technique integrates two levels of guidance to control both soft tissue and bone resection, potentially enhancing surgical precision and predictability.

This randomized controlled clinical trial is designed to compare the effectiveness of dual digitally guided crown lengthening with the conventional technique in patients presenting with gummy smile due to altered passive eruption (Type B1).

Eighteen systemically healthy patients aged 18-40 years will be recruited and randomly assigned into two equal groups. The control group will undergo conventional crown lengthening using clinical measurements and manual surgical techniques. The intervention group will be treated using a dual digitally fabricated surgical guide based on digital smile design, CBCT analysis, and intraoral scanning.

Clinical and patient-reported outcomes will be assessed at baseline and during follow-up periods. The primary outcome is the gain in clinical crown length measured at 3 months postoperatively. Secondary outcomes include operating time, pain (VAS), patient satisfaction (VAS), gingival margin level, probing depth, gingival index, plaque index, bleeding on probing, keratinized gingival height, and gingival thickness.

The results of this study are expected to provide evidence regarding the benefits of digital guidance in periodontal esthetic surgery and its potential to improve clinical outcomes and patient experience.

Study Type

Interventional

Enrollment (Actual)

24

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 Locations

  • Syria
      • Damascus, Syria
        • School of Dental Medicine

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 presenting with gummy smile due to altered passive eruption (Type B1)
  • Presence of at least 6 maxillary anterior teeth indicated for crown lengthening
  • Good oral hygiene and ability to maintain plaque control
  • Systemically healthy patients

Exclusion Criteria:

  • Poor oral hygiene
  • Smokers
  • Pregnancy or lactation
  • Systemic diseases affecting periodontal tissues
  • Previous periodontal surgery in the study area
  • Active periodontal disease
  • Presence of periapical pathology in the study area
  • Ongoing orthodontic treatment
  • Gummy smile due to skeletal or muscular causes

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Crown Lengthening
Participants in this group will undergo conventional surgical crown lengthening based on clinical evaluation and manual measurements. The procedure includes gingivectomy and osseous resection performed according to standard periodontal surgical protocols without the use of digital guidance.
Procedure: Conventional Crown Lengthening
Conventional surgical crown lengthening performed based on clinical examination and manual measurements. The procedure includes gingival recontouring and osseous resection carried out according to standard periodontal surgical protocols without the use of digital guidance.
Experimental: Dual Digitally Guided Crown Lengthening
Participants in this group will receive crown lengthening using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT analysis to guide both soft tissue and bone resection, aiming to improve surgical precision and predictability.
Procedure: Dual Digitally Guided Crown Lengthening
Crown lengthening performed using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT imaging to guide both soft tissue and bone resection, enhancing surgical accuracy and predictability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gain in Clinical Crown Length
Time Frame: Baseline and 3 months postoperatively
Change in clinical crown length (mm), measured from the incisal edge to the gingival margin using a periodontal probe, to assess the effectiveness of crown lengthening procedures.
Baseline and 3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Operating Time
Time Frame: During surgery (intraoperative)
Total duration of the surgical procedure measured in minutes from the first incision to completion of osteotomy.
During surgery (intraoperative)
Postoperative Pain (VAS)
Time Frame: 24 hours, 7 days, and 14 days postoperatively
Patient-reported pain assessed using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable).
24 hours, 7 days, and 14 days postoperatively
Patient Satisfaction (VAS)
Time Frame: 7 days and 3 months postoperatively
Patient satisfaction with the esthetic and functional outcome measured using a Visual Analogue Scale (VAS).
7 days and 3 months postoperatively
Relative Gingival Margin Level
Time Frame: Baseline, 1 week, and 3 months postoperatively
Measurement of gingival margin position (mm) relative to a fixed reference point to evaluate soft tissue stability.
Baseline, 1 week, and 3 months postoperatively
Probing Depth
Time Frame: Baseline and 3 months postoperatively
Periodontal probing depth (mm) measured at standardized sites using a periodontal probe.
Baseline and 3 months postoperatively
Gingival Index (GI)
Time Frame: Baseline and 3 months postoperatively
Assessment of gingival inflammation using the Gingival Index scoring system.
Baseline and 3 months postoperatively
Plaque Index (PI)
Time Frame: Baseline and 3 months postoperatively
Assessment of oral hygiene status using the Plaque Index scoring system.
Baseline and 3 months postoperatively
Bleeding on Probing (BOP)
Time Frame: Baseline and 3 months postoperatively
Presence or absence of bleeding upon gentle probing, expressed as a percentage of bleeding sites.
Baseline and 3 months postoperatively
Keratinized Gingival Height
Time Frame: Baseline, 1 week, and 3 months postoperatively
Width of keratinized gingiva (mm) measured from the gingival margin to the mucogingival junction.
Baseline, 1 week, and 3 months postoperatively
Gingival Thickness
Time Frame: Baseline and 3 months postoperatively
Thickness of gingival tissue (mm) measured using transgingival probing or ultrasound methods.
Baseline and 3 months postoperatively

Collaborators and Investigators

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

Sponsor

Arab International University

Collaborators

Damascus University

Investigators

  • Principal Investigator: Raghad Alrefaai, DDs, Damascus University
  • Study Chair: Razan Khattab, PhD, Damascus University
  • Study Director: Saleh Al Kurdi, PhD, Arab International 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 (Actual)

July 1, 2024

Primary Completion (Actual)

October 15, 2025

Study Completion (Actual)

February 25, 2026

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DN-10062024-3764

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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