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Not yet recruitingNCT06652217splintUpdated Oct 22, 2024

Analysis of Occlusal Force Distribution in Digital and Conventional Occlusal Splint

An interventional study of Digitally manufactured occlusal splint. and conventionally manufactured occlusal splint in Bruxism, sponsored by Cairo University. Not yet recruiting. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

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).
02

Conditions studied

  • Bruxism

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03

In context

Bruxism

151 studies on the registry are indexed under Bruxism; 39 are open to participants now.

This study's planned enrollment of 24 is below the median of 39 across 94 interventional studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 to materials.
  • Extensive temporomandibular disorder that renders the stabilizing splints not to be the treatment of choice.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • 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.

  • 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

Interventions

  • DeviceDigitally 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

  • Deviceconventionally 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.

06

What researchers measure

Primary outcomes

  1. occlusal force distribution

    the distribution of force between right and left side will be assessed using occlusosense device

    Time frame: the outcome will be measured immediately after the device insertion

Secondary outcomes

  1. cost effectiveness

    the cost effectiveness will be measured using the following equation (CE ratio = C/E)

    Time frame: the outcome will be measured immediately after the device insertion

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — iam not going to share the IPD for privacy and security of the informations

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06652217
Lead sponsor
Cairo University
Responsible party
fatma hussein abd elmonem (teaching assistant, Cairo University) — Principal investigator
First posted
Oct 22, 2024
Start date
Oct 2024 (estimated)
Primary completion
May 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Oct 22, 2024

Study contacts

fatma H saleh, master of prosthodontics
Contact
fatma.hussein@dentistry.cu.edu.eg
+201011164489

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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