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)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Primary objectives:
Wound healing Score: the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: swelling of the soft tissue , color of the gingiva, probing pocket depth, bleeding index, plaque index, clinical attachment level. These signs were assessed at 1 week, 3 months and 6 months post-operative.
Operating time: the time needed to complete each procedure was calculated in minutes by using a stopwatch from the time of the first incision till the completion of bone removal.
Secondary objectives:
Patient satisfaction: was assessed using visual analogue scale at 24 hours, 7 days and 14 days post operatively. (Zero is for minimum pain and ten is for maximum pain).
Gingival margin stability: The position of gingival margin in relation to a reference point was evaluated immediately after surgery, 3 months and 6 months healing period .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Ain Shams University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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: Test Group
Eight patients indicated for ECL were treated using digitally assisted crown lengthening utilizing 3D printed surgical stents.
|
Computer guided Esthetic crown lengthening
|
|
Active Comparator: Control Group
Eight patients indicated for ECL were managed by conventional crown lengthening.
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Conventional Surgical Esthetic Crown Lengthening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound Healing
Time Frame: Change in soft tissue features from 1 week to 6 months post operative
|
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
Time Frame: During surgery
|
the time needed to complete each procedure from the first incision till the completion of bone removal
|
During surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: 1 day - 1 week - 2 weeks post operative
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will be assessed using numerical visual analogue scale (scale of zero - no pain to ten- maximum pain)
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1 day - 1 week - 2 weeks post operative
|
|
Gingival margin stability
Time Frame: Baseline - 3 months post operative - 6 months post operative
|
The position of gingival margin in reference to an index is measured from the incisal edge to the free gingival margin
|
Baseline - 3 months post operative - 6 months post operative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Guided gummy smile correction
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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