Computer Guided Esthetic Crown Lengthening
Primary Purpose
Altered Passive Eruption of Teeth, Guided Surgery, Gummy Smile
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional Esthetic crown lengthening
Computer guided Esthetic crown lengthening
Sponsored by
About this trial
This is an interventional treatment trial for Altered Passive Eruption of Teeth
Eligibility Criteria
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.
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test Group
Control Group
Arm Description
Eight patients indicated for ECL were treated using digitally assisted crown lengthening utilizing 3D printed surgical stents.
Eight patients indicated for ECL were managed by conventional crown lengthening.
Outcomes
Primary Outcome Measures
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
Operating time
the time needed to complete each procedure from the first incision till the completion of bone removal
Secondary Outcome Measures
Patient satisfaction
will be assessed using numerical visual analogue scale (scale of zero - no pain to ten- maximum pain)
Gingival margin stability
The position of gingival margin in reference to an index is measured from the incisal edge to the free gingival margin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05512312
Brief Title
Computer Guided Esthetic Crown Lengthening
Official Title
Treatment of Excessive Gingival Display Using Conventional Esthetic Crown Lengthening Versus Computer Guided Esthetic Crown Lengthening: (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
September 10, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altered Passive Eruption of Teeth, Guided Surgery, Gummy Smile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
Eight patients indicated for ECL were treated using digitally assisted crown lengthening utilizing 3D printed surgical stents.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Eight patients indicated for ECL were managed by conventional crown lengthening.
Intervention Type
Procedure
Intervention Name(s)
Conventional Esthetic crown lengthening
Intervention Description
Conventional Surgical Esthetic Crown Lengthening
Intervention Type
Procedure
Intervention Name(s)
Computer guided Esthetic crown lengthening
Intervention Description
Computer guided Esthetic crown lengthening
Primary Outcome Measure Information:
Title
Wound Healing
Description
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
Time Frame
Change in soft tissue features from 1 week to 6 months post operative
Title
Operating time
Description
the time needed to complete each procedure from the first incision till the completion of bone removal
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
will be assessed using numerical visual analogue scale (scale of zero - no pain to ten- maximum pain)
Time Frame
1 day - 1 week - 2 weeks post operative
Title
Gingival margin stability
Description
The position of gingival margin in reference to an index is measured from the incisal edge to the free gingival margin
Time Frame
Baseline - 3 months post operative - 6 months post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Computer Guided Esthetic Crown Lengthening
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