NCT03671668

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, we 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

35
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 Nov 2018

Shorter than P25 for not_applicable

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
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

September 13, 2018

Last Update Submit

October 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Crestal bone loss

    measuring crestal bone loss around implants using periapical x ray with parallel technique in millemeters

    6 to 12 months

Secondary Outcomes (1)

  • Patients satisfaction

    6 to 12 months

Study Arms (2)

Screw retained prosthesis on transmucosal abutments

ACTIVE COMPARATOR
Other: titanium bases using intra oral luting cement technique

Screw retained prosthesis on titanium bases

EXPERIMENTAL
Other: titanium bases using intra oral luting cement technique

Interventions

comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction

Screw retained prosthesis on titanium basesScrew retained prosthesis on transmucosal abutments

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

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Completely edentulous patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 14, 2018

Study Start

November 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 26, 2018

Record last verified: 2018-10