Digital Versus Conventional Guided Gingivectomy

NCT05969132 | Unknown

• 1 other identifier: FDASU-RecIM122209
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical study is to compare Fully digital to conventional guided Gingivectomy procedure in management of excessive gingival display caused by altered passive eruption type 1A. The main question it aims to answer is: Does the fully digital guided gingivectomy approach able to introduce a more precise, accuracy and reliability technique with more patient satisfaction compared to the conventional guided method?

Conditions

Altered Passive Eruption of Teeth

Keywords

gummy smile; excessive gingival display; Altered Passive Eruption; gingivectomy; fully digital guided

Outcome Measures

Primary Outcomes (1)

• Accuracy of both guides

  Intraoral digital scanning for obtaining gingival contour will be made immediately postsurgical, 4 weeks and 2 months after surgery and exported in STL files format. Diagnostic waxing-up on poured cast (for group 2) will be digitalized with a model scanner and exported in STL file format. Accuracy will be evaluated by: * Superimposing postoperative intraoral digital scanning STL files with virtually designed diagnostic waxing STL file (for group 1) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction. * Superimposing postoperative intraoral digital scanning STL files with digitized waxing-up STL file (for group 2) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction.

  Immediately postsurgical, 4 weeks and 2 months after surgery

Secondary Outcomes (1)

• Patient Satisfaction

  2 months

Study Arms (2)

Digital workflow-based Protocol

EXPERIMENTAL

Fully digital guided gingivectomy procedure

Procedure: Fully digital guided gingivectomy procedure

Mock-up workflow-based Protocol

ACTIVE COMPARATOR

Convectional guided gingivectomy procedure

Procedure: Convectional guided gingivectomy procedure

Interventions

Fully digital guided gingivectomy procedure PROCEDURE

1. Full history with clinical and radiographic examination (CBCT) to aid in patient's selection. 2. Supra- and sub-gingival debridement. 3. Oral hygiene instructions (OHI) 4. Presurgical intraoral scanning using an intraoral scanner (IOS) 5. Fabrication of the Gingivectomy guide: * Convert (DICOM) file to STL file then merged to STL file corresponding oral soft tissues 3D data obtained by IOS using software of surgical planning. * Digital waxing up with new desired positions of gingival margins and zenith points performed. * Designing Gingivectomy guide then exported to a 3D printer and mill a transparent resin gingivectomy guide. 6. Surgical Procedure: anesthetized the patient using local anesthesia, Surgical incision using 15c blade following CEJ anatomy will be made at each tooth using the Gingivectomy guide as reference to new gingival level and being careful to preserve the gingival papillae without involving the palatal surfaces. 7. Postoperative care

Digital workflow-based Protocol

Convectional guided gingivectomy procedure PROCEDURE

1. Full history with clinical and radiographic examination (CBCT) to aid in patient's selection. 2. Supra- and sub-gingival debridement with OHI 3. Gingivectomy guide fabrication: * Impressions and casts obtained. * Waxing-up included new positions of gingival margins and zenith points. * Silicone index with condensation silicone impression materials made with pressure on the cast to reproduce the details of the wax, then filled after setting with resin material and placed in the patient's mouth. * Resin mock-up trimmed with blade to define the correct new gingival level. * After the patient accept the mock-up design will used as Gingivectomy guide. 4. Surgical Procedure: anesthetized the patient using local anesthesia, Surgical incision using 15c blade following CEJ anatomy will be made at each tooth using the Gingivectomy guide as reference to new gingival level and being careful to preserve the gingival papillae without involving the palatal surfaces. 5. Postoperative care

Mock-up workflow-based Protocol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients complaining of Excessive gingival display (3mm or more gingival display at full smiling)
• Patients classified as Altered Passive Eruption Type 1A

You may not qualify if:

• Patients need restorative or orthodontic correction.
• Pregnant and lactating females.
• Heavy smoker ≥ 10 cigarettes/day.
• Poor oral hygiene.
• Patients with systemic diseases which could influence the outcome of the therapy e.g.
• (Diabetic patients).
• Heavy smoker ≥ 10 cigarettes/day.
• Vulnerable groups of patients e.g. (prisoners, handicapped patients and decisionally impaired individuals)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Fentistry Ain Shams university

Cairo, 11566, Egypt

Location

Related Publications (28)

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Study Officials

• Ahmed E. Amr, Ass. Prof.

  Faculty of dentistry Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Eslam O. Hashem, Master st.

CONTACT

+201100673726; eslamhashim@dent.asu.edu.eg

Doaa A. Khattab, Ass. Prof.

CONTACT

+201006814258; dr.doaa.adel-khattab@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The current investigation will be a single-blinded clinical trial. Blinding included the assessor, and the statistician. Its impossible for the operator who performed the surgical procedure to be blinded as the interventions will be completely different and the patient also.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: August 1, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

EG (1)