Edentulous Alveolar Ridge In MandibleNCT07271641
A Study Comparing Two Different Denture Base Materials in Implant Retained Overdentures
A study testing Conventional acrylic resin denture and Flexible resin denture in people with Edentulous Alveolar Ridge In Mandible and Edentulous Jaw, run by Al-Azhar University at 1 site in Egypt.
Trial 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'… Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge In Mandible, Edentulous Jaw, Edentulous Mouth
- What is being tested?
- Conventional acrylic resin denture and Flexible resin denture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbial Evaluation of Two Different Implant Retained Mandibular Overdentures (Randomized Clinical Trial)
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.
Read the detailed 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
- Conditions
- Edentulous Alveolar Ridge In Mandible, Edentulous Jaw, Edentulous Mouth, Implant Supported Overdenture, Attachments, Dental Implant
- Being tested
- Conventional acrylic resin denture, Flexible resin denture
- Keywords
- Dental Implants, Completely edentulous patients, Edentulous Ridge, Candida, Patient Satisfaction, Clinical Parameters
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous, Torulopsis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional acrylic resin dentureProcedure or surgery
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 dentureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Flexible resin denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Follow up visits were scheduled at denture insertion, 6, and 12 months
Secondary outcomes (3)
isolation of Candida albicans
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
Measured: Follow up visits were scheduled at denture insertion, 6, and 12 months
Patient satisfaction (Questionnaire)
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
Measured: Follow up visits were scheduled at denture insertion, 6, and 12 months.
Oral Health-Related Quality of Life (OHRQoL) (Questionnaire)
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.
Measured: Follow up visits were scheduled at denture insertion, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Jul 2024
- Primary completion1 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge In MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Taha Kamel Taha Alloush, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271641
- Sponsor's protocol ID
- 29.4.24
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbial Evaluation of Two Different Implant Retained Mandibular Overdentures (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07271641
- Acronym / sponsor ID
- 29.4.24
- Conditions
- Edentulous Alveolar Ridge In Mandible, Edentulous Jaw, Edentulous Mouth, Implant Supported Overdenture, Attachments, Dental Implant
- Keywords
- Dental Implants, Completely edentulous patients, Edentulous Ridge, Candida, Patient Satisfaction, Clinical Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mandibular complete dentures processed into heat cured acrylic resin | Active comparator | Procedure: Conventional acrylic resin denturemandibular 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 thermoplastic nylon denture | Experimental | Procedure: Flexible resin denturemandibular 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. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional acrylic resin dentureMandibular 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 or surgery | mandibular complete dentures processed into heat cured acrylic resin |
| Flexible resin dentureMandibular 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 or surgery | mandibular thermoplastic nylon denture |
Primary outcome
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.
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
3 secondary outcomes
isolation of Candida albicans
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Patient satisfaction (Questionnaire)
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months.
Oral Health-Related Quality of Life (OHRQoL) (Questionnaire)
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Yes. Study Protocol and Clinical Study Report
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional acrylic resin denture and Flexible resin denture in people with Edentulous Alveolar Ridge In Mandible and Edentulous Jaw, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket depth (Depth of gingival sulcus) (time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.