Effect of T-scan Occlusal Analysis and Adjustment vs Articulating

NCT ID: NCT05051878

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2021-12-30

Brief Summary

The aim of this study is to compare two different methods for occlusal analysis of implant - supported prosthesis (T-scan and conventional method with articulating papers) regarding the stresses transmitted to the implants.

Detailed Description

Four implants will be inserted, two implants in canine regions and two implants in lower second premolar regions.

After 3 months, two identical overdentures will be constructed for the patient on implants.

The occlusion of each one of the two identical prostheses will be adjusted intraorally but according to different occlusal analysis:

• Group (A) : occlusal adjustments for the overdenture will be done according to articulating paper analysis.
• Group (B) :- occlusal adjustments for the overdenture will be done according to T-scan analysis.

The two prostheses will be retained on dummy implants on acrylic cast and will be loaded under chewing simulator.

The strain developed around the dummy implants will be measured. The data will be recorded manually then will be transferred into digital form. The obtained data will be recorded, tabulated and statistically analyzed using the appropriate tests for comparison within each group.

Conditions

Occlusion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

articulating paper occlusal adjustment

occlusal adjustments of implant supported prosthesis according to articulating paper occlusal analysis

Group Type: EXPERIMENTAL

articulating paper

Intervention Type: OTHER

articulating paper occlusal analysis

T-scan occlusal analysis

occlusal adjustments of implant supported prosthesis according to T-scan occlusal analysis

Group Type: EXPERIMENTAL

T-scan

Intervention Type: DEVICE

occlusal analysis T-scan

Interventions

T-scan

occlusal analysis T-scan

Intervention Type: DEVICE

articulating paper

articulating paper occlusal analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age range from 55-65.
• Radiographic examination should reveal bone height more than 10 mm and crestal bone width not less than 5 mm of the inter-foraminal region.
• Residual bone and mucosa should be free from any pathological signs, bony undercuts, or neoplasia.
• Adequate salivary flow.
• Adequate mouth opening.
• Adequate inter-arch space.

Exclusion Criteria

• Systemic diseases affecting metabolism of bone e.g uncontrolled diabetes, bone diseases, hyperparathyroidism and renal disease.
• Severe blood diseases (hemophilia etc.).
• Severe vascular heart disease.
• Liver Problems.
• Cerebral infarction .
• Severe immunodeficiency.
• Patients who are undergoing strong chemotherapy.
• Excessive alcohol consumption.
• Severe neuropsychiatric disease, mental disability, and narcotic drug addict
• Uncooperative patients

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmoud Alafandy, professor

Role: STUDY_DIRECTOR

oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University

Ahmed Osama, professor

Role: STUDY_DIRECTOR

oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University

Omar ELsadat, lecturer

Role: STUDY_DIRECTOR

oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University

Locations

Faculty of dentistry, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

OCCLUSAL EVALUATION

Identifier Type: -

Identifier Source: org_study_id