Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-26 @ 1:30 AM
Study NCT ID:
NCT03221361
Status:
UNKNOWN
Last Update Posted:
2017-07-19
First Post:
2017-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maximum Biting Force of Inject Able Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Maximum Biting Force of Injectable Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients (A Randomized Clinical Trial)
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: