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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03391063
Other study ID # Reinforced complete denture
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 29, 2017
Last updated January 4, 2018
Start date February 1, 2018
Est. completion date July 1, 2018

Study information

Verified date January 2018
Source Cairo University
Contact mahmoud abdallah abdelomttaleb, B.D.S
Phone 01016344118
Email m.abdalla2022@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 38
Est. completion date July 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 55 Years to 65 Years
Eligibility Inclusion Criteria:

1. Male or female patient with age range (45-55) completely edentulous and in good medical condition.

2. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.

3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.

4. Free from any tempro-mandibular joint disorder.

5. The patients have good oral hygiene.

6. The edentulous ridges should be covered by firm healthy mucosa.

7. Healthy and co-operative patients.

Exclusion Criteria:

1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).

2. Previous history of radiotherapy or chemotherapy.

3. Any skeletal problem dictates surgical intervention.

4. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.

5. Patient with xerostomia or excessive salivation.

6. No intraoral soft and hard tissue pathosis.

7. Psychiatric problems.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
polyamide
metal reinforced polyamide denture base material
heat cured acrylic resin
conventional heat cured acrylic resin denture base material

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (1)

Vojdani M, Giti R. Polyamide as a Denture Base Material: A Literature Review. J Dent (Shiraz). 2015 Mar;16(1 Suppl):1-9. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary chewing efficiency assessed using sieving method chewing efficiency of the mandibular complete denture 6 weeks
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