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Clinical Trials/CTRI/2024/05/067902
CTRI/2024/05/067902Not yet recruitingPhase 3 4

Comparison of two vestibuloplasty techniques to evaluate denture stability in complete denture patients with severely resorbed anterior mandibular ridge: A Prospective Clinical Study

Dr Rohit Kumar Singh1 site in 1 country20 target enrollmentStarted: June 17, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
The pre-prosthetic surgery is expected to enhance the stability of the mandibular complete denture which will improve the quality of life of complete edentulous patients

Study Overview

Brief Summary

a Vestibuloplasty is a surgical procedure designed to deepen the oral vestibule, which is the space between the lips, cheeks, and gums. This procedure is commonly employed in pre-prosthetic surgery to address issues related to the insufficient height of the alveolar ridge, and in periodontology to augment the amount of keratinized gingiva. The alveolar ridge is the bony ridge that contains the tooth sockets in the upper and lower jaws. An adequate height of the alveolar crest is crucial for the stability and retention of removable dentures, especially when implants are not used for support.1-2 Several conditions can contribute to the reduction of vestibular depth, including a prolonged absence of teeth, traumatic injuries to the alveolar ridge, or severe periodontitis (inflammation and infection of the supporting structures of the teeth). When there is a lack of an adequate residual alveolar ridge, it can compromise the successful rehabilitation with removable dentures. Removable dentures are often preferred for economic reasons, making vestibuloplasty an indispensable procedure in cases where the vestibular depth is reduced.3-4 Many vestibular deepening techniques have been described since the beginning of the era of surgery namely, Kazanjian, Godwin, Trauner, Clark, Sulcus deepening, Obwegeser, Howe, Steinhauser, Tortorelli. Vestibuloplasty repositions mucosa, and muscle insertions, and increases the denture flange area in turn stability of the prosthesis. All procedures are associated with varying degrees of success. Disadvantages associated with existing procedures made the clinician rethink modifications so that the modifications can overcome the disadvantages.

·       This clinical study planned to achieve adequate vestibular depth using Clark’s and sulcus deepening vestibuloplasty so that stability of the mandibular denture will be improved.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Edentulous patient with a minimum bone height of 15 mm and less than 5 mm of vestibular depth in the mandibular anterior region.
  • Patients with ASA (American Society of Anaesthesiology) class I and II conditions.

Exclusion Criteria

  • Patients with uncontrolled systemic disorders like hepatic, respiratory, cardiac, endocrine, or metabolic impairment which make the patient unfit for surgical procedure.

Outcomes

Primary Outcomes

The pre-prosthetic surgery is expected to enhance the stability of the mandibular complete denture which will improve the quality of life of complete edentulous patients

Time Frame: Patients will be checked on day zero, day 7, day 15, and in 4th week for satisfactory surgical wound healing. Only after satisfactory healing, we will proceed with the denture fabrication process. The denture will be delivered around 4-6 weeks after soft tissues show at least grade 4(very good) healing.

Secondary Outcomes

  • Better retention for denture(after 6 months of delivering the dentures)

Investigators

Sponsor
Dr Rohit Kumar Singh
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Prof Dr Nagaraj M

ESIC Dental College & Hospital

Study Sites (1)

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