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NCT Number: NCT07575087

Comparison of Dual Digitally Guided vs Conventional 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

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Key information

Conditions

Gingival Overgrowth Gingival Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Conventional Crown Lengthening

Procedure

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.

Dual Digitally Guided Crown Lengthening

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. Probing Depth

    Time frame: Baseline and 3 months postoperatively

    Periodontal probing depth (mm) measured at standardized sites using a periodontal probe.

  6. Gingival Index (GI)

    Time frame: Baseline and 3 months postoperatively

    Assessment of gingival inflammation using the Gingival Index scoring system.

  7. Plaque Index (PI)

    Time frame: Baseline and 3 months postoperatively

    Assessment of oral hygiene status using the Plaque Index scoring system.

  8. 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.

  9. 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.

  10. Gingival Thickness

    Time frame: Baseline and 3 months postoperatively

    Thickness of gingival tissue (mm) measured using transgingival probing or ultrasound methods.

Sponsors and collaborators

Lead sponsor

Arab International University

Other

Collaborators

  • Damascus University

Registry information

Official study title

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

Acronym: DIGICROWN

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

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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