Accuracy of Stackable Double Periodontal Guide in Esthetic Crown Lengthening
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The goal of this clinical trial is to find out if a new digital surgical guide helps dentists perform esthetic crown lengthening more accurately than the current digital guide in adults with a gummy smile caused by altered passive eruption. Esthetic crown lengthening is a procedure that reshapes the gums and the bone around the teeth to show more of the natural tooth. The main questions this study aims to answer are: Does the new digital guide help dentists reshape the bone and gums more accurately? Does the new digital guide improve healing, the appearance of the gums, the time needed for surgery, and participants' satisfaction with the results? Researchers will compare a new stackable digital guide with the current digital guide to see if the new design provides more accurate and predictable results. Participants will:
- Be randomly assigned to have surgery using either the new digital guide or the current digital guide.
- Have dental examinations, digital mouth scans, and three-dimensional dental X-rays before surgery to plan their treatment.
- Have esthetic crown lengthening surgery using the assigned guide.
- Return for follow-up visits right after surgery and again about 6 weeks and 6 months later so researchers can check healing and compare the planned treatment with the final result.
- Answer questions about their satisfaction with the treatment and any pain medicine they used after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedFirst Posted
Study publicly available on registry
October 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
October 23, 2026
October 1, 2026
2 years
July 25, 2026
October 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in accuracy of both guides
Evaluation of the degree of matching of the post operative actual gingival zenith points with the virtual predicted presurgical plan. Intraoral digital scanning for both groups will be obtained preoperative, immediately after surgery, and follow up appointments at 6 weeks and 6 months after surgery and exported in STL file format then it will be superimposed on the digitally designed diagnostic STL file to obtain statistical differences.The accuracy can be measured by comparing the planned surgery and the actual result of the surgery Linear measurement in millimeters.
6 months
Secondary Outcomes (6)
Bone level accuracy
6 months
Gingival margin stability
6 Months
Pink Esthetic Score
6 months
Surgical time
time of the surgery
Patient satisfaction
2 weeks
- +1 more secondary outcomes
Study Arms (2)
Stackable double digital periodontal guide
EXPERIMENTALParticipants undergo esthetic crown lengthening using a stackable double digital periodontal guide. The guide consists of separate gingivectomy and ostectomy components that are assembled during surgery to guide bone reduction.
Conventional double digital periodontal guide
ACTIVE COMPARATORParticipants undergo esthetic crown lengthening using a conventional one-piece double digital periodontal guide
Interventions
A custom-made, 3D-printed digital surgical guide used during esthetic crown lengthening. The guide consists of two detachable components: a gingivectomy guide for soft tissue incision and an ostectomy guide that is joined after flap reflection and positioned directly on the alveolar bone to guide bone reduction. The guide is designed using merged cone-beam computed tomography (CBCT) and intraoral scan data to improve the accuracy of bone reshaping.
A custom-made, one-piece 3D-printed digital surgical guide used during esthetic crown lengthening. The guide directs both the gingivectomy and ostectomy based on the planned treatment using intraoral scan data . After flap reflection, the guide is repositioned to guide bone reduction from the soft tissue level.
Eligibility Criteria
You may qualify if:
- Patients both genders aged from 21-40 years
- Patients complaining of Excessive gingival display (3mm or more gingival display at full smiling).
- Patients with Altered passive eruption (APE) type 1 B Coslet GJ et al., 1977).
- Patients have thick gingival phenotype (thickness of gingiva is ≥ 1 mm) (Greenberg J et al., 1976).
- Patients with healthy periodontium and no active periodontal disease, with good plaque control and stable gingival health prior to surgery.
You may not qualify if:
- Pregnant and lactating females.
- Poor oral hygiene.
- Smokers.
- Patients with systemic diseases which could influence the outcome of the therapy e.g. (Diabetic patients, bleeding disorders).
- Patients on immunosuppressive therapy or long-term corticosteroids.
- Patients on antiresorptive or antiangiogenic drugs (e.g., bisphosphonates, denosumab) that impair bone healing.
- Patients with vertical maxillary excess, dentoalveolar extrusion with deep bite, attrition, short lip length, hyperactive mobile upper lip.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinding included the assessor, and the statistician.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
July 25, 2026
First Posted
October 23, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
October 23, 2026
Record last verified: 2026-10