T-Scan Study of Occlusion in Case of Implant Retained Overdenture
T-Scan Evaluation for Different Types of Occlusion in Mandibular Overdenture Retained By Two Splinted Mini Implants (In Vivo Study)
1 other identifier
interventional
14
1 country
1
Brief Summary
Materials and methods: fourteen patients were selected according to the inclusion criteria, the participants were stratified equally into two groups, patients were assigned to receive either monoplane or lingualized occlusal schemes to their overdentures. For each patient placement of two mini-implants in the mandible at the canine region was done, bar joint attachment was used to splint the mini implants. Each implant was 2.5 mm in diameter and 10 mm in length. T-scan occlusal load analysis records were done in centric occlusion , the records was used to analyze the biting force of the denture as a Full Closure Force Movie recording, then Time vs. Force Graph of that Force Movie is accomplished. T-scan records were taken three times for each patient in the two groups ,Immediately after loading ,three months and six months of loading.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 9, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedMarch 25, 2019
March 1, 2019
11 months
March 9, 2019
March 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
traumatic dental occlusion by T-Scan III
To evaluate the stress distribution in mandibular overdenture retained by two splinted mini implants using monoplane and lingualized occlusion in setting of teeth using T-Scan.
6months
Study Arms (2)
Percentage of force in monoplane occlusion
ACTIVE COMPARATORDifferent occlusal scheme evaluation using tscan
Percentage of force in lingualized occlusion
ACTIVE COMPARATORDifferent occlusal scheme evaluation using tscan
Interventions
Monoplane and lingualized occlusion effect on force distribution
Monoplane and lingualized occlusion effect on force distribution
Eligibility Criteria
You may qualify if:
- Age range from 50-65. Free from any systemic diseases affecting bone metabolism.
- Free from tempromandibular joint disorders.
- Having normal ridge relationship.
- Adequate interarch space.
- No parafunctional habits.
- Residual ridge with adequate height covered by firm dense fibrous mucoperiosteum with no sharp spicules.
You may not qualify if:
- systemic diseases affecting metabolism of bone e.g bone diseases, hyperparathyroidism and renal diseases
- Severe blood disease (hemophilia ect)
- Severe vascular heart disease
- Liver problems
- Severe immunodeficiency .Patients who are undergoing strong chemotherapy,Irradiated patients or requiring hard or soft tissue grafting of the proposed implant site.
- Uncooperative patients who have no understanding of the need for regular follow-up .Patient diagnosed with neuromuscular disorders, para functional habits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, 11517, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heba T Mohamed, Doctor
Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 9, 2019
First Posted
March 25, 2019
Study Start
February 20, 2018
Primary Completion
January 15, 2019
Study Completion
February 1, 2019
Last Updated
March 25, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share