Clinical trial NCT05051878: Effect of T-scan Occlusal Analysis and Adjustment vs Articulating
Official title: Effect of T-scan Occlusal Analysis and Adjustment vs Articulating Paper on Stresses Transmitted to Single Mandibular Implant Supported Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occlusion
Keywords: t-scan
occlusal analysis
implant supported prosthesis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 7
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: stresses around implants
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Ain Shams University
Study officials:
affiliation: oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University
name: Mahmoud Alafandy, professor
role: STUDY_DIRECTOR
affiliation: oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University
name: Ahmed Osama, professor
role: STUDY_DIRECTOR
affiliation: oral & maxillofacial prosthodontics Faculty of Dentistry Ain-shams University
name: Omar ELsadat, lecturer
role: STUDY_DIRECTOR
References: