Computer Guided Esthetic Crown Lengthening

Gummy Smile Clinical Trial

Official title:

Treatment of Excessive Gingival Display Using Conventional Esthetic Crown Lengthening Versus Computer Guided Esthetic Crown Lengthening: (A Randomized Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512312
• Other study ID #: Guided gummy smile correction
• Status: Completed
• Phase: N/A
• Start date: January 2, 2022
• Est. completion date: October 12, 2022

Study information

• Verified date: December 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 12, 2022
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altered Passive Eruption of Teeth
• Exanthema
• Guided Surgery
• Gummy Smile

Intervention

Procedure:
• Conventional Esthetic crown lengthening
Conventional Surgical Esthetic Crown Lengthening
• Computer guided Esthetic crown lengthening
Computer guided Esthetic crown lengthening

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Operating time	the time needed to complete each procedure from the first incision till the completion of bone removal	During surgery
Secondary	Patient satisfaction	will be assessed using numerical visual analogue scale (scale of zero - no pain to ten- maximum pain)	1 day - 1 week - 2 weeks post operative
Secondary	Gingival margin stability	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