Clinical trial NCT05512312: 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
Overall status: COMPLETED
Phase: NA
Conditions: Altered Passive Eruption of Teeth
Guided Surgery
Gummy Smile
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: Inclusion Criteria:

1. Males and females within age range of 20-40 years.
2. Systemic (medically) free individuals.
3. Excessive gingival display in the esthetic zone (more than 3mm of gingival display at full smiling)
4. Patients with good oral hygiene.

Exclusion Criteria:

1. Smokers (15)
2. Teeth with compromised periodontium.
3. Pregnant and lactating females.
4. The vulnerable group: patients with mental or physical disabilities.
5. Patients with parafunctional habits.
6. Medications that affect periodontal wound healing.
7. Periodontal surgery in the esthetic zone in the past 6 months.

Primary outcomes:
measure: Wound Healing
timeFrame: Change in soft tissue features from 1 week to 6 months post operative
measure: Operating time
timeFrame: During surgery
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 day - 1 week - 2 weeks post operative
measure: Gingival margin stability
timeFrame: Baseline - 3 months post operative - 6 months post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: