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

NCT07271641 | Completed DMC

• 1 other identifier: 29.4.24
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Dental Implants; Completely edentulous patients; Edentulous Ridge; Candida; Patient Satisfaction; Clinical Parameters

Outcome Measures

Primary Outcomes (2)

• Pocket depth (Depth of gingival sulcus)

  The depth of the gingival sulcus will be measured around each implant using a graduated periodontal probe. This probe will be inserted between the oral sulcular epithelium and the implant with minimal pressure. The distance from the tip of the probe and the free gingival margin will be measured and recorded to the nearest millimeter. Four readings were recorded at the middle of the four surfaces, buccal, lingual, mesial, and distal. The mean of the four readings will be considered as the pocket depth for this group at the chosen time.

  Follow up visits were scheduled at denture insertion, 6, and 12 months

• Plaque index

  Amount of plaque accumulation was graded from (0 to 3) where: Grade 0: No plaque detected by passing the side of probe along the implant. Grade 1: Film of plaque detected by probing. Grade 2: Moderate accumulation of soft debris, which can be seen by the naked eye. Grade 3: Too much soft matter within the sulcus, gingival margin, and adjacent implant surface. For each group, four readings were recorded at the middle of the four surfaces, buccal, lingual, mesial, and distal. The mean of the four readings was considered as the plaque index for this group at the chosen times

  Follow up visits were scheduled at denture insertion, 6, and 12 months

Secondary Outcomes (3)

• isolation of Candida albicans

  Follow up visits were scheduled at denture insertion, 6, and 12 months

• Patient satisfaction (Questionnaire)

  Follow up visits were scheduled at denture insertion, 6, and 12 months.

• Oral Health-Related Quality of Life (OHRQoL) (Questionnaire)

  Follow up visits were scheduled at denture insertion, 6, and 12 months

Study Arms (2)

mandibular complete dentures processed into heat cured acrylic resin

ACTIVE COMPARATOR

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.

Procedure: Conventional acrylic resin denture

mandibular thermoplastic nylon denture

EXPERIMENTAL

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.

Procedure: Flexible resin denture

Interventions

Conventional acrylic resin denture PROCEDURE

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.

mandibular complete dentures processed into heat cured acrylic resin

Flexible resin denture PROCEDURE

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

mandibular thermoplastic nylon denture

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 4470351, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous; Mouth, Edentulous; Torulopsis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 9, 2025
• Study Start: July 15, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 20, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Start Date: After publication End Date: 3 years
• Access Criteria: After publication through the corresponding author

Locations

EG (1)