Micro-surgical Treatment of Gummy Smile

Pain, Postoperative Clinical Trial

Official title:

Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401826
• Other study ID #: PER3-3-1
• Status: Completed
• Phase: N/A
• Start date: September 6, 2020
• Est. completion date: June 6, 2022

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.

Description:

The conventional approach: Anesthesia will be given followed by bone sounding using William graduated periodontal probe and measuring the pocket depth (using magnification loupes and microsurgical blades)

• Marking the bleeding points

• An internal bevel incision is made followed afterwards by a sulcular incision.

• The gingival collar is eliminated.

• Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery and an apical position of the bone 2-3mm beyond CEJ.

• Mattress suture (6.0) is made

The intervention approach:

Surgery is done the same as in the conventional approach but without opening a flap, gaining access via a tunneling instrument and piezo tips for osteoplasty

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 6, 2022
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with healthy systemic condition.

2. Adult patients ? 18 years old.

3. The presence of the six upper anterior teeth.

4. Patients who have short clinical crowns due to altered passive eruption classified as Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977).

5. Absence of sites with attachment loss and probing depth (PD) >3 mm.

6. Keratinized gingiva of at least 2mm width (Pontoriero and Carnevale, 2001).

7. Compliance with good oral hygiene.

8. Patients accepts 6-months follow-up period (cooperative patients).

9. Patients provides an informed consent.

Exclusion Criteria:

1. Presence of prosthetic crowns

2. Extensive restorations

3. Extensive incisal edge attrition.

4. Smokers ? 10 cigarettes / day

5. Pregnant females

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Tunneling micro-surgical crown lengthening approach using piezo-surgery
excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling
• Micro-surgical crown lengthening approach using Piezosurgery
excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medecine-CU	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain VAS	Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative	48 hours
Secondary	Mid-buccal gingival margin level	Periodontal probe with William's graduation will be used to measure the distance from a prefabricated grooved stent vertically- to the level of the gingival margin at the mid-buccal surface (measured at baseline, 3 and 6 months postoperatively)	6 months
Secondary	Post-Surgical Patient Satisfaction.	Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )	6 months
Secondary	Pink Esthetic Score	The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence. All other variables will be assessed by comparison to a reference tooth.	6 months
Secondary	Post-Surgical swelling	Absent: no swelling, Slight: intraoral swelling at the operated area, Moderate: moderate intraoral swelling at the operated area and Intense: intensive extra oral swelling extending beyond the operated area. (Assessed in day 7 and 14 postoperatively)	14 days