Micro-surgical Treatment of Gummy Smile

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04401826
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: Tunneling micro-surgical crown lengthening approach using piezo-surgery; Procedure: Micro-surgical crown lengthening approach using Piezosurgery	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial
• Actual Study Start Date: Sep 6, 2020
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The conventional approach Conventionnal ECL using piezosurgery and microsurgical tools	Procedure: 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.
Active Comparator: The intervention approach: Conventionnal ECL with tunneling using piezosurgery and microsurgical tools	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

Outcome Measures

Primary Outcome Measures

1. Pain VAS [48 hours]

   Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative

Secondary Outcome Measures

1. Mid-buccal gingival margin level [6 months]

   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)

2. Post-Surgical Patient Satisfaction. [6 months]

   Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )

3. Pink Esthetic Score [6 months]

   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.

4. Post-Surgical swelling [14 days]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Oral and Dental Medecine-CU	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marie-line Sherif Sourour, Principal Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT04401826
• Other Study ID Numbers: PER3-3-1
• First Posted: May 26, 2020
• Last Update Posted: Dec 7, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Dec 7, 2021