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Digital Versus Conventional Guided Gingivectomy

NCT05969132 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-08-16

No results posted yet for this study

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

Interventions

PROCEDURE

Fully digital guided gingivectomy 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

PROCEDURE

Convectional guided gingivectomy 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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ahmed E. Amr, Ass. Prof. · Faculty of dentistry Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-10-01
Completion
2024-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05969132 on ClinicalTrials.gov