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A Study Comparing Two Different Denture Base Materials in Implant Retained Overdentures

A

Al-Azhar University

Status

Completed

Conditions

Attachments
Edentulous Jaw
Edentulous Mouth
Implant Supported Overdenture
Edentulous Alveolar Ridge In Mandible
Complete Edentulism
Dental Implant

Treatments

Procedure: Flexible resin denture
Procedure: Conventional acrylic resin denture

Study type

Interventional

Funder types

Other

Identifiers

NCT07271641
29.4.24

Details and patient eligibility

About

The aim of removable prosthodontics is not only to restore lost oral structures but also to preserve the remaining tissues. Implant-retained overdentures have shown superior outcomes over conventional dentures by reducing residual ridge resorption, enhancing prosthesis support and retention, and improving patients' quality of life. Retention can be further optimized through the use of various attachment systems such as bars, studs, magnets, and telescopic crowns.

Traditional PMMA denture bases have limited flexibility, making their extension into soft-tissue undercuts challenging. The introduction of flexible resin materials has improved adaptation to deeper undercuts, enhancing retention while minimizing patient discomfort and absorbing functional stresses. Additionally, flexible resins may reduce microbial colonization by improving blood circulation to the underlying mucosa and supporting salivary defense mechanisms against Candida albicans.

Recently, innovative attachment systems such as Novaloc have been developed, featuring PEEK retentive caps and an amorphous diamond-like carbon coating to minimize wear and maintain long-term retention. Their versatile design allows better accommodation of gingival variations and contributes to improved patient satisfaction and treatment success.

Full description

The present study will be performed to compare the difference in microbial accumulation, quality of life and patient satisfaction for implant retained mandibular overdenture using both conventional PMMA and flexible denture base materials.

16 Patients will be equally divided into two treatment groups: Group 1: Each patient in this group will receive conventional maxillary and mandibular complete dentures made of heat-cured acrylic resin. In the mandible, two implants were inserted and retained by Novaloc attachments. Group 2: Patients in this group will receive the same type of treatment as the patients in group1 but the mandibular overdentures were made of the flexible acrylic resin

Enrollment

16 patients

Sex

All

Ages

60 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Edentulous patients were chosen between the ages of 60 to 70 years old
  2. All patients' ridges were covered with firm mucosa,
  3. free from any signs of inflammation or ulceration, exhibit adequate height and width of the residual alveolar ridge have sufficient inter arch space.
  4. Patients were free from any metabolic or bone disorder that contraindicate implant installation.

Exclusion criteria

  1. Patients with oral or systemic diseases
  2. patients with xerostomia or excessive salivation.
  3. Patients with parafunctional habits (bruxism or clenching) or history of temporo-mandibular dysfunction or brain disorders or psychiatric disorders.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 2 patient groups

mandibular complete dentures processed into heat cured acrylic resin
Active Comparator group
Description:
mandibular complete dentures made of heat-cured acrylic resin polymethylmethacrylate (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Novaloc attachments.
Treatment:
Procedure: Conventional acrylic resin denture
mandibular thermoplastic nylon denture
Experimental group
Description:
mandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Novaloc attachments.
Treatment:
Procedure: Flexible resin denture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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