Effect of T-scan Occlusal Analysis and Adjustment vs Articulating

Effect of T-scan Occlusal Analysis and Adjustment vs Articulating Paper on Stresses Transmitted to Single Mandibular Implant Supported Prosthesis

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.

Study Overview

• Status: Completed
• Conditions: Occlusion
• Intervention / Treatment: Other: articulating paper; Device: T-scan

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Faculty of Dentistry, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: articulating paper occlusal adjustment; occlusal adjustments of implant supported prosthesis according to articulating paper occlusal analysis	Other: articulating paper; articulating paper occlusal analysis
Experimental: T-scan occlusal analysis; occlusal adjustments of implant supported prosthesis according to T-scan occlusal analysis	Device: T-scan; occlusal analysis T-scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stresses around implants	stresses transmitted around implants supporting the prosthesis by stain gauge	baseline

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Mahmoud Alafandy, professor, oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University; Study Director: Ahmed Osama, professor, oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University; Study Director: Omar ELsadat, lecturer, oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: t-scan; occlusal analysis; implant supported prosthesis
• Other Study ID Numbers: OCCLUSAL EVALUATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No