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Maximum Biting Force of Inject Able Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients

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ClinicalTrials.gov Identifier: NCT03221361
Recruitment Status : Unknown
Verified July 2017 by Ahmed saad eid, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 18, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed saad eid, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Biting Force Device: thermoplastic complete denture Device: conventional acrylic resin complete denture Not Applicable

Detailed Description:

For all included patients and in the first visit, panoramic x ray is taken then a primary impression will be made for the maxillary and mandibular arches using irreversible hydrocolloid material. Then, the maxillary and mandibular impressions will be poured with a hard stone to get a study casts.

A double layer wax spaced self-cured acrylic resin will be used to prepare a special tray for each patient. The special tray using also irreversible hydrocolloid material makes a secondary impression. The secondary impressions will be poured using extra hard dental stone to get the master casts.

At this point the patient is given a number to enter one of the two groups either the intervention group or the control group.

For the intervention group, the framework of the thermoplastic resin is usually thicker than that of the metal. At this time the framework wax pattern will be ready for spruing and flasking using specially designed flasks. The injection of the thermoplastic resin will be started after the elimination of wax and the procedure will be done using thermopress machine.

In the third visit for all patients, the finished denture bases of thermoplastic resin will be tried inside the patient's mouth to check its fitting, retention, reciprocation and opposing occlusion.

Then, a face bow record will be taken for each patient which will be used to mount the maxillary cast on the articulator. For mounting the mandibular cast, either an intercuspal or centric jaw relation will be used. Artificial teeth will be set up and tried in in the patient's mouth in the fourth visit to check esthetics, phonetics, lip support, occlusion and uneven pairing.

In The fifth visit, the finished prosthesis will be adjusted and delivered to each patient, the outcome data will be collected using a questionnaire, and a salivary swap is taken for microbial count detection.

Complete dentures will be constructed for all patients; Group- I: patients will receive complete dentures from thermoplastic material Group- II: patients will receive complete dentures from conventional Poly methyl Methacrelate resin.

Then use Gnatho-dynamometer for measure the biting force for all patients

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective , parallel , randomized clinical trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:

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.
Primary Purpose: Health Services Research
Official Title: Maximum Biting Force of Injectable Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients (A Randomized Clinical Trial)
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Thermoplastic resin group
Thermoplastic complete denture placement is done
 Device: thermoplastic complete denture
a device used ti substitute teeth for edentlous patient made of thermoplastic resin
Placebo Comparator: conventional acrylic resin group
conventional acrylic resin complete denture placement is done
 Device: conventional acrylic resin complete denture
A device used to substitute the teeth for edentlous patient made of acrylic resin


Outcome Measures
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Primary Outcome Measures :
  1. maximum biting force [ Time Frame: 0,2,4,6 months ]
    using gnathodynamometer to compare the difference between maximum biting force


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • - Bone irregularities , soft tissue ulcerations , severe undercuts
  • Serious systemic problem
  • Patient with xerostomia
  • Severely resorbed ridge
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221361


Contacts
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Contact: Amal A Rekaby, Ph.D 01149977997 ahmed_saad@dentistry.cu.edu.eg
Contact: Mostafa Helmy, Ph.D 01149977997 ahmed_saad@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
More Information
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Publications:
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.

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Responsible Party: Ahmed saad eid, Dr., Cairo University
ClinicalTrials.gov Identifier: NCT03221361    
Other Study ID Numbers: 28711170100211
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data will be available through contact by email of the princible investigator ( ahmed_saad@dentistry.cu.ed.eg)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No