NCT05051878

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

September 10, 2021

Last Update Submit

January 21, 2023

Conditions

Occlusion

Keywords

t-scanocclusal analysisimplant supported prosthesis

Outcome Measures

Primary Outcomes (1)

  • stresses around implants

    stresses transmitted around implants supporting the prosthesis by stain gauge

    baseline

Study Arms (2)

articulating paper occlusal adjustment

EXPERIMENTAL

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

Other: articulating paper

T-scan occlusal analysis

EXPERIMENTAL

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

Device: T-scan

Interventions

T-scanDEVICE

occlusal analysis T-scan

T-scan occlusal analysis
articulating paperOTHER

articulating paper occlusal analysis

articulating paper occlusal adjustment

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 21, 2021

Study Start

October 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

EG(1)