Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Co/Cr Single Dentures.

NCT03675594 | Unknown DMC

• 1 other identifier: 28912240102212
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

• Steps in short: Undergoing the conventional steps of maxillary single denture construction till the step of framework construction that will be designed and constructed using CAD/CAM after optical scanning of the master cast ( 2 frameworks to cover the palate and crest of the ridge : one made of titanium and the other made of cobalt/chromium) then conventional steps will be undergone including bite, Try-in and delivery ending by measuring the denture retention.
• Number of visits \& follow up period : Visits: will be 5-6 visits for each patient. Follow up period: 6.5 months (immediately post-insertion then after 1 week then after 3 months for the first type then 2 weeks washout period and the same for the second type)

Conditions

Edentulous Mouth

Keywords

Dislodgement force; Digital denture; CAD/CAM metallic dentures

Outcome Measures

Primary Outcomes (1)

• Retention of single denture

  the dislodgement force of the denture will be assessed

  6.5 months

Study Arms (2)

intervention arm

EXPERIMENTAL

the group of participants will take the CAD/CAM titanium denture bases and assessment during and after the first 3 months after delivery of the first type.

Device: CAD/CAM titanium denture base

intervention arm 2

EXPERIMENTAL

the same group of participants will take the CAD/CAM cobalt/chromium denture bases and assessment during and after the second 3 months after delivery of the second type.

Device: CAD/CAM cobalt/chromium denture bases

Interventions

CAD/CAM titanium denture base DEVICE

metallic denture base made of titanium

intervention arm

CAD/CAM cobalt/chromium denture bases DEVICE

metallic denture bases made of cobalt/chromium

intervention arm 2

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.
• The edentulous ridges should be covered by firm healthy mucosa.
• Angle class I maxillomandibular relationship
• Healthy and co-operative patients.

You may not qualify if:

• Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than I 0 cigarettes/day).
• Previous history of radiotherapy or chemotherapy.
• Any skeletal problem dictates surgical intervention.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, Manyal, 12554, Egypt

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• iman rady, professor

  head of evidence based dentistry

  STUDY DIRECTOR

Central Study Contacts

Amal el rekaby, professor

CONTACT

0122258794; prosthetic@dentistry.cu.edu.eg

ahmed saad, lecturer

CONTACT

0118976584; ahmed_saad@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the participants will not be told which type they received till obtaining the final results of both types.Outcomes will be collected only by the supervisor.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of prosthodontics

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 18, 2018
• Study Start: December 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: September 30, 2019
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)