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

Maximum Biting Force of Injectable Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients (A Randomized Clinical Trial)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03221361
Enrollment
21
Registered
2017-07-18
Start date
2017-08-01
Completion date
2017-12-01
Last updated
2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biting Force

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.

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

Interventions

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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, 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.

Intervention model description

prospective , parallel , randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
maximum biting force0,2,4,6 monthsusing gnathodynamometer to compare the difference between maximum biting force

Contacts

Primary ContactAmal A Rekaby, Ph.D
ahmed_saad@dentistry.cu.edu.eg01149977997
Backup ContactMostafa Helmy, Ph.D
ahmed_saad@dentistry.cu.edu.eg01149977997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026