NCT03221361

Brief Summary

In this research we are comparing the new thermoplastic material side by side with the conventional poly methyl methacrylate for fully edentulous patients measuring their maximum biting force whether it is going to be higher by the new polyamide material.

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
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

Same day

First QC Date

July 16, 2017

Last Update Submit

July 18, 2017

Conditions

Biting Force

Outcome Measures

Primary Outcomes (1)

  • maximum biting force

    using gnathodynamometer to compare the difference between maximum biting force

    0,2,4,6 months

Study Arms (2)

Thermoplastic resin group

ACTIVE COMPARATOR

Thermoplastic complete denture placement is done

Device: thermoplastic complete denture

conventional acrylic resin group

PLACEBO COMPARATOR

conventional acrylic resin complete denture placement is done

Device: conventional acrylic resin complete denture

Interventions

thermoplastic complete dentureDEVICE

a device used ti substitute teeth for edentlous patient made of thermoplastic resin

Thermoplastic resin group
conventional acrylic resin complete dentureDEVICE

A device used to substitute the teeth for edentlous patient made of acrylic resin

conventional acrylic resin group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Completely edentulous
  • No bone irregularities
  • Good oral hygiene
  • Should be co-operative
  • Medically free
  • No TMJ Problems

You may not qualify if:

  • \- Bone irregularities , soft tissue ulcerations , severe undercuts
  • Serious systemic problem
  • Patient with xerostomia
  • Severely resorbed ridge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1. Brunello DL, Mandikos MN (1998) Construction faults, age, gender, and relative medical health: factors associated with complaints in complete denture patients. J Prosthet Dent 79, 545-554. 2. Craig RG, Powers JM, et al. Restorative Dental Materials. 11th ed. St Louis: Mo, Mosby; 2002. pp. 636-689. 3. O Bricn WJ. Dental Material and their selection. 4th ed. Chicago: Quintessence Publishing Co, Inc.; 2008. pp. 75-113. 4. Marei MK. Reinforcement of denture base resin with glass fillers. J Prosthodont. 1999; 8: 18-26. 5. Vojdani M, Khaledi AAR. Transverse Strength of Reinforced Denture Base Resin with Metal Wire and E-Glass Fibers. J Dent Tehran Univ Med Scien. 2006; 3: 167-172. 6. Vojdani M, Bagheri R, Khaledi AAR. Effects of aluminum oxide addition on the flexural strength, surface hardness, and roughness of heat-polymerized acrylic resin. Journal of Dental Sciences. 2012; 7: 238-244. 7. Matthews E, Smith DC. Nylon as a denture base material. Br Dent J. 1955; 98: 231-237. 8. Negrutiu Meda et al (2005) Thermoplastic resins for flexible framework removable partial dentures. TMJ 55:3 9. Hazari, P., Bhoyar, A., Mishra, S. K., Yadav, N. S., & Mahajan, H. (2015). A Comparison of Masticatory Performance and Efficiency of Complete Dentures Made with High Impact and Flexible Resins: A Pilot Study. Journal of Clinical and Diagnostic Research : JCDR, 9(6), ZC29-34. doi:10.7860/JCDR/2015/12207.6089 10. Rueggeberg FA. From Vulcanite to vinyl, a history of resins in restorative dentistry, J Prosthet Dent. 2002; 87(4):364-79.

    BACKGROUND

Central Study Contacts

Amal A Rekaby, Ph.D

CONTACT

01149977997ahmed_saad@dentistry.cu.edu.eg

Mostafa Helmy, Ph.D

CONTACT

01149977997ahmed_saad@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The study will be blinded regarding the statistician who is responsible for data analysis. The participant patients will be blinded. The outcome assessor for biting force can be blinded during the measurement, the operator cannot be blinded.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: prospective , parallel , randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 16, 2017

First Posted

July 18, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

data will be available through contact by email of the princible investigator ( ahmed\_saad@dentistry.cu.ed.eg)