Digital Versus Conventional Guided Gingivectomy
- Conditions
- Altered Passive Eruption of Teeth
- Interventions
- Procedure: Convectional guided gingivectomy procedureProcedure: Fully digital guided gingivectomy procedure
- Registration Number
- NCT05969132
- Lead Sponsor
- Ain Shams University
- 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?
- Detailed Description
Nowadays, the concept of smile and dental esthetics is no longer limited to the teeth. The essentials of a smile involve the relationship between the three primary components: the teeth, lip framework, and the gingival scaffold.
The term "pink aesthetics" refers to the aesthetics of gingival tissues, which play a significant influence in smile aesthetics.
Excessive gingival display while smiling, also usually known as a "gummy smile," is a common esthetic concern among dental patients and, being largely viewed as unesthetic, leads many patients to seek some form of treatment to address the issue.
Gummy smile (Excessive gingival display) is recognized by the American Academy of Periodontology (AAP) as a deformity and mucogingival condition that affects the area around the teeth.
This condition could be caused by many etiological factors: short lip, hypermobile/hyperactive lip, short clinical crowns, dentoalveolar extrusion, altered passive eruption (APE), gingival hyperplasia, and vertical maxillary excess.
Altered passive eruption defined as "the gingival margin in the adult is located incisal to the cervical convexity of the crown and removed from the cementoenamel junction of the tooth".
Altered passive eruption classified into two main classes according to the relationship of the gingiva to the anatomic crown and furthermore subdivided those classes according to the position of the osseous crest. The two types are subdivided into four categories: 1A, 1B and 2A, 2B.
The diagnosis of APE is made on a collective clinical and radiographic examination, it begins with analyzing the repose during a natural smile followed by analyzing the gingival display, the alveolar crest level, as well as the lip line of the patient.
Determination can be made whether a gingivectomy alone will suffice or a gingival flap will be needed with or without ostectomy will depend of the diagnosis of APE and classification of each case.
The selection of one technique over another depends on several patient related factors such as esthetics, clinical crown to root ratio, root proximity, root morphology, furcation location, individual tooth position, collective tooth position and ability to restore the teeth.
The gingivectomy approach alone is used when 3 mm gingival tissue or greater exists from bone to gingival crest, and an adequate attached gingiva will remain after surgery (APE type IA).
A diagnostic wax-up then an intraoral fabricated mock-up representing the desired outcome can assist in the selection of proper planning of the need for periodontal surgical approach.
Diagnostic mock-up fabricated using a temporary bis-acrylic resin with a putty guide directly from the wax-up can be used to provide the patient and clinician with an evaluation of the future outcome and can be used as a surgical guide for gingivectomy procedures.
The major limitations with conventional guided gingivectomy procedure would be the time consumed during making and modifying conventional wax-ups as well as the unpredictable estimate of where the gingival margin should be.
Utilization of digital workflows allowed the enhancement of communication and might improve the predictability of contemporary gingivectomy approach.
The introduction of computer-aided design and computer-aided manufacturing (CAD-CAM) techniques has helped surgeons perform more precise and predictable surgery and contributed to improved esthetics.
By combining the use of Digital Smile Design and CAD/CAM technology with (3D) printing, a surgical guide for Gingivectomy procedure could be produced.
The aim of the present study will be to evaluate accuracy and reliability of digital guided method of gingivectomy procedure using CAD CAM technology versus conventional method using resin Mock-up as gingivectomy surgical guide.
Research Question "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?"
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- Patients complaining of Excessive gingival display (3mm or more gingival display at full smiling)
- Patients classified as Altered Passive Eruption Type 1A
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mock-up workflow-based Protocol Convectional guided gingivectomy procedure Convectional guided gingivectomy procedure Digital workflow-based Protocol Fully digital guided gingivectomy procedure Fully digital guided gingivectomy procedure
- Primary Outcome Measures
Name Time Method Accuracy of both guides Immediately postsurgical, 4 weeks and 2 months after surgery 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.
- Secondary Outcome Measures
Name Time Method Patient Satisfaction 2 months A 5-item custom made questionnaire will give to the patients to be answered for assessing their satisfaction with the whole procedure and the results of the procedure performed.
1. Post-operative pain (POP): It will be evaluated indirectly based on the mean consumption (in mg) of analgesics (ibuprofen)\* after the surgical procedures (Wessel and Tatakis, 2008).
2. Post-operative results
3. Post-operative swelling: It will be reported by the patients through the first week (7 days) postsurgically based on the Verbal Rating Scale (VRS) values (absent, slight, moderate and severe) (García et al., 2008).
4. Surgery time
5. Procedure as a whole
Trial Locations
- Locations (1)
Faculty of Fentistry Ain Shams university
🇪🇬Cairo, Egypt