NCT03674554

Brief Summary

On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, the investigators want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

September 13, 2018

Last Update Submit

September 14, 2018

Conditions

Edentulous JawEdentulous Alveolar RidgeEdentulous Mouth

Outcome Measures

Primary Outcomes (1)

  • Abutment screw loosening

    Measuring device :Clinical visual inspection / Measuring unit:Binary

    12 months

Secondary Outcomes (6)

  • Prosthetic screw loosening

    12 months

  • Prosthetic screw fracture

    12 months

  • Abutment screw fracture

    12 months

  • Veneer fracture

    12 months

  • Framework fracture

    12 months

  • +1 more secondary outcomes

Study Arms (2)

titanium bases group

EXPERIMENTAL

full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique

Procedure: titanium bases using intra oral luting cement technique

transmucosal abutment group

EXPERIMENTAL

a full-arch screw-retained implant prosthesis with transmucosal abutment

Procedure: transmucosal abutment

Interventions

titanium bases using intra oral luting cement techniquePROCEDURE

a full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique

titanium bases group
transmucosal abutmentPROCEDURE

a full-arch screw-retained implant prosthesis with transmucosal abutment

transmucosal abutment group

Eligibility Criteria

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

You may qualify if:

  • \- Completely edentulous patients
  • Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture
  • Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created
  • Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism
  • Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent )

You may not qualify if:

  • \- Patients having a medical condition that absolutely contraindicates implant placement.
  • Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent )
  • Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day).
  • Patients who are having complete lower denture
  • Patients who have history of bruxism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Universty

Cairo, 01234, Egypt

Location

MeSH Terms

Conditions

Jaw, EdentulousMouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth DiseasesTooth Diseases

Central Study Contacts

mostafa said hosny, M.Sc. 2018

CONTACT

0100779234drdental88@gmail.com

Amr hosny elkadem, phd

CONTACT

01001162401amrelkhadem@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Allocation sequence generation will be performed by the Senior supervisor. Enrolment of participants will be performed by the principle investigator where the patients will be assessed for eligibility.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 17, 2018

Study Start

October 1, 2018

Primary Completion

September 1, 2019

Study Completion

July 1, 2020

Last Updated

September 17, 2018

Record last verified: 2018-09

Locations

EG(1)