Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint (splint)

Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint (Randomized Clinical Trial)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Bruxism
• Intervention / Treatment: Device: Digitally manufactured occlusal splint.; Device: conventionally manufactured occlusal splint

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: fatma H saleh, master of prosthodontics; Phone Number: +201011164489; Email: fatma.hussein@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:• Age range from 20 to 60 years old.

• Medically healthy patients.
• Patients with signs (as teeth attrition, muscles hypertrophy, and increased muscles activity) and symptoms (as muscles pain, headache, patient reporting) of bruxism for the last 6 months with no condylar or disc attrition.
• Fully dentate with presence of first molar in both arches
• Patients with good oral hygiene.
• Absence of any intra-oral pathological condition. Exclusion Criteria:• Patients with a history of psychosomatic disease.
• Patients with addiction to alcohol, drugs, or analgesics.
• Pregnant patients.
• Patients with malignant disease.
• Acute events such as trauma or inflammation.
• Bisphosphonate therapy within the last 5 years.
• Removable dental prostheses.
• Known hypersensitivity to materials.
• Extensive temporomandibular disorder that renders the stabilizing splints not to be the treatment of choice.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occlusal force distribution	the distribution of force between right and left side will be assessed using occlusosense device	the outcome will be measured immediately after the device insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cost effectiveness	the cost effectiveness will be measured using the following equation (CE ratio = C/E)	the outcome will be measured immediately after the device insertion

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Bruxism; Anti-Infective Agents; Antifungal Agents; Dermatologic Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: 2497; ethics comittee (Other Identifier: St. Franzikus Hospital Winterberg)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: iam not going to share the IPD for privacy and security of the informations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No