Suspended

Comparative Study Of Biting Force Of Injection Molded PEEK and Bre.Flex Materials For Bounded Removable Partial Dentures (Randomized Clinical Trial)

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What is being tested

bre.flex

+ PEEK

Other
Who is being recruted

Bites and Stings+1

+ Poisoning

+ Wounds and Injuries

From 45 to 55 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: March 2017
See protocol details

Summary

Principal SponsorCairo University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2017

Actual date on which the first participant was enrolled.

The patient will be treated in visits designated as follows: Visit 1: Preoperative records, clinical, radiographic examination (panoramic and periapical x-rays for evaluation the crown-root ratio, the apical condition of the abutment and their alveolar bone support of abutment) and primary impression will be performed with irreversible hydro-colloid impression material (alginate), The impressions will be poured with type IV dental stone to obtain diagnostic casts . Visit 2: Maxillary Face-bow will be recorded. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the interarch distance and occlusal plane. Visit 3: primary surveying is performed. Special trays will be constructed and Mouth preparation will be performed by preparing guiding planes and rests seats will be prepared opposing to the edentulous area. Final impression will be taken by elastomeric impression material. The impression will be poured into type IV dental stone in order to obtain master cast. The master cast will be surveyed. The proposed design will be as follows: metal framework base saddle for edentulous areas on both sides connected with palatal strap. Aker's clasp on all abutments with buccal retention. Visit 4: the metal framework is tried into the patient's mouth. Jaw relation is recorded. Visit 5: The denture base will be tried in with acrylic teeth in patient's mouth. Visit 6: the denture base of the partial denture will be processed incorporation with the metal framework into the two different materials to be evaluated. The first group will receive the partial denture in which the metal framework incorporated with the denture base fabricated from PEEK material. The second group will receive the partial denture in which the metal framework incorporated with the denture base material fabricated from BRE-FLEX. Visit7,8,9: clinical measurement will be performed for one month in three visits.

Official TitleComparative Study Of Biting Force Of Injection Molded PEEK and Bre.Flex Materials For Bounded Removable Partial Dentures (Randomized Clinical Trial)
Principal SponsorCairo University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 45 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bites and StingsPoisoningWounds and InjuriesChemically-Induced Disorders

Criteria

Inclusion Criteria: * i. All patients must have Kennedy class III modification I upper partially edentulous ridges. ii. The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession. iii. Male or female patient with age range (45-55) and in good medical condition iv. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance. v. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. vi. Free from any tempro-mandibular joint disorder. vii. The patients have good oral hygiene and low caries index. Exclusion Criteria: * i. Patients having abnormal habits as bruxism or clenching ii. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included. iii. Teeth with compromised bone support. iv. Patient with xerostomia or excessive salivation. v. Patient with abnormal tongue behavior and/or size.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
patients will receive partial denture constructed from breflex material

Group II

Experimental
patients will receive partial denture constructed from PEEK material

Study Objectives

Primary Objectives

Study Centers

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