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Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint

NCT06652217 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-10-22

No results posted yet for this study

Summary

Each eligible patient will be randomly into one of two groups:

Group A: The digital splint group, digital splint will be constructed to each patient.

Group B: The conventional splint group, conventional splint will be constructed to each patient.

* For both groups, thorough clinical examination, scaling and root-planning will be done. Patient will receive a motivational oral hygiene program with detailed explanation regarding the study process and outcome expectations.
* A precise history and clinical examination will be done by (F.M) under supervision of Dr S.G.

The digital splint construction method:

* First, complete arch intraoral digital scans of the maxillary and mandibular arches will be performed using the intra oral scanner following the scanning protocol recommended by the manufacturer.
* For inter maxillary relation recording using optical jaw tracking device, step-by-step procedure for tracking and recording the maxillomandibular relationship and mandibular motion by using an optical jaw tracking system will be illustrated to the patient.
* The occlusal device will be designed using a CAD software program.
* The occlusal device will be printed using a 3D printer
* The occlusal device will be finished and polished manually.

The conventional splint construction method:

* The first step is making an impression using a quick-setting addition polyvinyl siloxane impression material. A stone model will be obtained after pouring the impression using extra-hard dental stone.
* In the second visit a face bow transfer and a centric relation record will be utilized to mount the casts on a semi adjustable articulator.
* For centric relation recording, a jig will be made with an incisal plateau from modeling plastic impression compound and the jig will be inserted between the central incisors. To measure centric relation as precisely as possible (by avoiding translational movement in the temporomandibular joint),
* The jig will be adjusted with a scalpel to create a distance of no more than 2 mm between the maxillary and mandibular arches. Then the relation will be recorded using a fast-setting polyvinyl siloxane occlusal registration material. The occlusal registrations will be trimmed to the buccal cusp tips to be transferred accurately to the articulator without interference.
* After mounting of the centric relation the protrusive record will be taken and the horizontal condylar angle will be adjusted accordingly.
* The device will be fabricated from clear prosthetic resin. Production followed a standardized protocol with a minimum inter maxillary thickness of 1.5 mm and a buccal extension to 1 mm below the survey line.
* The device will be finished and occlusion will be adjusted on the articulator. outcomes assessment:

1. Occlusal force distribution will be measured using osslusosense.
2. Cost effectiveness will be assessed using the following equation(CE ratio = C/E).

Conditions

  • Bruxism

Interventions

DEVICE

Digitally manufactured occlusal splint.

digitally manfactured occlusal splint using intra oral scanner and jaw traccking device for data acqusition and 3d printing for manfacturing of the device

DEVICE

conventionally manufactured occlusal splint

the occlusal device will be manufactured conventionally using impression and and anterior deprogramer with bite registeration material for data aquesition and usual construction method using clear acrylic.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-05-31
Completion
2025-06-30

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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 NCT06652217 on ClinicalTrials.gov