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

NCT ID: NCT03221361

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biting Force

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective , parallel , randomized clinical trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Thermoplastic resin group

Thermoplastic complete denture placement is done

Group Type ACTIVE_COMPARATOR

thermoplastic complete denture

Intervention Type DEVICE

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

conventional acrylic resin group

conventional acrylic resin complete denture placement is done

Group Type PLACEBO_COMPARATOR

conventional acrylic resin complete denture

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

thermoplastic complete denture

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

Intervention Type DEVICE

conventional acrylic resin complete denture

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed saad eid

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amal A Rekaby, Ph.D

Role: CONTACT

01149977997

Mostafa Helmy, Ph.D

Role: CONTACT

01149977997

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

28711170100211

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.