NCT03887975

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

March 9, 2019

Last Update Submit

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 COMPARATOR

Different occlusal scheme evaluation using tscan

Procedure: Monoplane Occlusion

Percentage of force in lingualized occlusion

ACTIVE COMPARATOR

Different occlusal scheme evaluation using tscan

Procedure: Lingualized occlusion

Interventions

Monoplane and lingualized occlusion effect on force distribution

Percentage of force in monoplane occlusion

Monoplane and lingualized occlusion effect on force distribution

Percentage of force in lingualized occlusion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Dental Occlusion, Traumatic

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Heba T Mohamed, Doctor

    Ain Shams University

    PRINCIPAL INVESTIGATOR

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
Model Details: Completely edentulous patients
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

Locations