Computer Guided Esthetic Crown Lengthening
Treatment of Excessive Gingival Display Using Conventional Esthetic Crown Lengthening Versus Computer Guided Esthetic Crown Lengthening: (A Randomized Clinical Trial)
1 other identifier
interventional
16
1 country
1
Brief Summary
The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.
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 Jan 2022
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
January 2, 2022
CompletedFirst Submitted
Initial submission to the registry
June 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2022
CompletedApril 3, 2023
December 1, 2022
8 months
June 5, 2022
March 31, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Wound Healing
the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: color of the gingiva (C) (a score of 0-2) 0=no redness, 1=moderate redness, 2=pronounced redness
Change in soft tissue features from 1 week to 6 months post operative
Operating time
the time needed to complete each procedure from the first incision till the completion of bone removal
During surgery
Secondary Outcomes (2)
Patient satisfaction
1 day - 1 week - 2 weeks post operative
Gingival margin stability
Baseline - 3 months post operative - 6 months post operative
Study Arms (2)
Test Group
ACTIVE COMPARATOREight patients indicated for ECL were treated using digitally assisted crown lengthening utilizing 3D printed surgical stents.
Control Group
ACTIVE COMPARATOREight patients indicated for ECL were managed by conventional crown lengthening.
Interventions
Conventional Surgical Esthetic Crown Lengthening
Computer guided Esthetic crown lengthening
Eligibility Criteria
You may qualify if:
- Males and females within age range of 20-40 years.
- Systemic (medically) free individuals.
- Excessive gingival display in the esthetic zone (more than 3mm of gingival display at full smiling)
- Patients with good oral hygiene.
You may not qualify if:
- Smokers (15)
- Teeth with compromised periodontium.
- Pregnant and lactating females.
- The vulnerable group: patients with mental or physical disabilities.
- Patients with parafunctional habits.
- Medications that affect periodontal wound healing.
- Periodontal surgery in the esthetic zone in the past 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching Assistant, Faculty of Dentistry, Misr International University
Study Record Dates
First Submitted
June 5, 2022
First Posted
August 23, 2022
Study Start
January 2, 2022
Primary Completion
September 10, 2022
Study Completion
October 12, 2022
Last Updated
April 3, 2023
Record last verified: 2022-12