Skip to main content
OpenTrials
Completed

NCT Number: NCT07271641

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

  1. Pocket depth (Depth of gingival sulcus)

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

    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.

  2. Plaque index

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

    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

Secondary outcomes

  1. isolation of Candida albicans

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

    A sterile swab will be rubbed on the intaglio surface of the denture. The swab will be placed in a tube containing 1 ml phosphate buffered saline solution and sonicated for 5 minutes at 35 kHz. - Serial decimal dilutions (100 to 10-2)will be prepared from the sonicated swab solution. - 100 µl of the sonicated solution will be inoculated on Sabouraud's dextrose agar at 37°C for 48 hours. - After incubation, the agar plate will be retrieved, and the number of colonies will be counted and tabulated for statistical analysis

  2. Patient satisfaction (Questionnaire)

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

    Participant satisfaction will be measured using a visual analog scale (VAS) questionnaire. The questions include the appearance, ease of cleaning, speaking ability, eating comfort, and overall satisfaction of their dentures.

    Participants will marked the amount of satisfaction on a 100-mm-length line (0 = no satisfaction at all and 100 = complete satisfaction). At a location that corresponded to the subject's subjective emotion, a pencil mark was drawn across the horizontal line. The distance in millimeters between the left end limit and the pencil mark point, which represents the subject's VAS score, will then be used to calculate satisfaction. The subject's perception of the prosthesis improves with a higher score. Using the VAS scores, satisfaction levels were categorized as follows: completely unsatisfied (0-31), somewhat unhappy (>31-50), slightly satisfied (>50-79), and satisfied (>79). The questionnaire was given to the patients in Arabic

  3. Oral Health-Related Quality of Life (OHRQoL) (Questionnaire)

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

    The oral health impact profile (OHIP-14) questions will be utilized to assess OHRQoL. The questions are composed of seven domains: functional limitations (pronouncing sounds, sense of taste), physical pains (painful aching, comfort on eating), psychologic discomforts (self-consciousness, feeling tense), physical disabilities (unsatisfactory diet, interrupting meals), psychologic disabilities (difficult to relax, embarrassment), social disabilities (irritability with people, difficulty in jobs), and handicapping (life in general, inability to function). The responses for questions are never (=1), hardly ever (=2), occasionally (=3), fairly often (=4), and very often (=5). Lower scores indicate increased satisfaction, and higher scores indicate decreased satisfaction.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Clinical and Microbial Evaluation of Two Different Implant Retained Mandibular Overdentures (Randomized Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.