Retentive Strength of Denture AdhesivesPhase 1NCT05063422
Retentive Strength of Denture Adhesives on Various RR Ridges
A Phase 1 study testing polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose in people with Retentive Strength of Denture Adhesives, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
To compare the retentive strength of different form of commercially available denture adhesives (paste, powder and cushion) on different form of residual ridges. To evaluate the effect of various denture adhesives on efficiency of complete dentures in patients with different alveolar ridges. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Retentive Strength of Denture Adhesives
- What is being tested?
- polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Aug 2022to 17 Aug 2023
- Phase
- Phase 1
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- edentulous patient willing to undergo new complete denture treatments and willing to visit the clinic for denture adjustment as a recall patient
- Healing period of at least 2 months after extraction.
Who cannot join
- Difficulty responding to questionnaire
- Use of metallic base denture
- Xerostomia
- Ill-fitting dentures
- Neuromuscular disorder
- Smoking habits
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- Debilitating diseases
- Immunocompromised
- Maxillofacial defects
- Use a tissue conditioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retentive Strength of Various Dental Adhesives on Various Types of Residual Ridged
To compare the retentive strength of different form of commercially available denture adhesives (paste, powder and cushion) on different form of residual ridges.
To evaluate the effect of various denture adhesives on efficiency of complete dentures in patients with different alveolar ridges.
Read the detailed description
- Prior approval from ethical committee has been taken (Annexure-D)
- As per protocol all patients presenting will be examined in general opd and those patients in need of rehabilitation of their missing teeth will be referred to Prosthodontics dept.
- Patients will undergo history and complete oral examination after informed consent (Annexure-B). On the basis of these information the patient will be selected for the study acc to exclusion and inclusion criteria.
- The patients will then categorized into three groups based on clinical and radiographic features of ridges according to Wical-Swoope classification.
- A well-constructed denture will be fabricated and all the post op complaints will be resolved.
- Three forms of denture adhesives will be used including powder, cream and strips for all three resorption classes as described by Wical-Swoope.
- A digital spring scale will be used to record the reading , All the measurements will be recorded in grams
- Retentive strength will be recorded first before application of the adhesives for baseline retention strength.
- Patient with denture in his mouth will be instructed to maintain max non-forced intercuspation for fives minutes. Atfer that with mouth opened and lower lip relaxed in order to avoid losing peripheral seal tip of the spring scale will be placed at the margin of denture in recess to lingual frenum. Traction forced will be then applied until denture is detached, the max retention force being recorded by sping scale. This procedure will be repeated thrice and mean value will be calculated.
- A second reading will be recorded after application of adhesive in similar manner
- Mean increase in denture retention strength will be calculated by subtracting denture retention strength without adhesive from denture retentive strength with adhesive for both study products
- The scores calculated will be filled in Performa (annexure-A)
- The obtained data will be then used to compare diff form of commercially availble denture adhesives (pastes, powder and cushion) for their mean increase in retention strength.
- Then patient will be instructed about how to apply denture adhesives (based on manufacturer' instructions)
- The patient will fill out two attributed questionnaires, before and 1 week after using the denture adhesive. In the questionnaire the satisfaction rating will be determined using valid questionnaires with seven evaluation items: general satisfaction, ability to speak, ease of cleaning, stability, retention, comfort and mastication performance (VAS? Likert scale?)
- The quantitative variable, age of the patients and retention strength was presented as mean+- SD. The qualitative varaible like sex was presented as frequency and percentages. T-test was used to determine the existence if difference of mean retention strength b/w the two form of denture adhesives.
- Data were analyzed using ANOVA and Chi-square tests in SPSS software version 25 software (SPSS version 25.0, SPSS Inc; Chicago, IL, USA) (P<.05)
The score calculated will be filled in the performa (Annexure-A)
- Conditions
- Retentive Strength of Denture Adhesives
- Being tested
- polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose
- Keywords
- alveolar ridge resorption, denture adhesives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymyxin b/trimethoprim ophthalmic, Carboxymethyl celluloseDrug
3 forms of denture adhesives from each brands are used to compare the retentive strength on highly resorbed ridges
| Study group | Role | What they receive |
|---|---|---|
| Mild Resorption of mandibular ridge | Experimental | Loss of upto 1/3 of original vertical height Receives: Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose |
| Moderate Resorption of mandibular ridge | Experimental | 2. Moderate Resorption: Loss of upto 1/3 to 2/3 of original vertical height Receives: Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose |
| Severe Resorption of mandibular ridge | Experimental | 3. Severe Resorption: Loss of 2/3 or more of original vertical height Receives: Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the retentive strength of various adhesives on various types of residual ridges using Spring scale
To compare the retentive strengths of different form of commercially available dentures adhesives
Measured: 1 year
Secondary outcomes (1)
To evaluate the effect of various denture adhesives on efficiency of complete denture in patient with different alveolar ridges using a well structured questionnaire
To evaluate the effect of various denture adhesives on efficiency of complete denture in patient with different alveolar ridges using a well structured questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start18 Aug 2022
- Primary completion17 Aug 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retentive Strength of Denture AdhesivesStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Maria Shakoor, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063422
- Sponsor's protocol ID
- Denture adhesive
- Status last verified
- Apr 2024
- First submitted
- 24 Jun 2021
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maqsood A, Shahidan WNS, Abbasi MS, Salahuddin A, Das G, Ahmed N, Heboyan A. Subjective Evaluation of Denture Adhesives in Mandibular Complete Denture Patients: A Randomized Controlled Trial. Health Sci Rep. 2026 Feb 25;9(3):e71897. doi: 10.1002/hsr2.71897. eCollection 2026 Mar.
PubMed 41767362Ahmed N, Abbasi MS, Salahuddin A, Tariq L, Siraj S, Das G, Suleman G, Vohra F, Heboyan A. Comparative Analysis of Adhesive Retention and Denture Weight in Different Residual Ridge Morphologies: A Cross-Over Randomized-Controlled Trial. Clin Exp Dent Res. 2025 Feb;11(1):e70118. doi: 10.1002/cre2.70118.
PubMed 40127129
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retentive Strength of Various Dental Adhesives on Various Types of Residual Ridged
- ClinicalTrials.gov ID
- NCT05063422
- Acronym / sponsor ID
- Denture adhesive
- Conditions
- Retentive Strength of Denture Adhesives
- Keywords
- alveolar ridge resorption, denture adhesives
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 1 Oct 2021 (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.
To compare the retentive strength of different form of commercially available denture adhesives (paste, powder and cushion) on different form of residual ridges.
To evaluate the effect of various denture adhesives on efficiency of complete dentures in patients with different alveolar ridges.
Detailed description
- Prior approval from ethical committee has been taken (Annexure-D)
- As per protocol all patients presenting will be examined in general opd and those patients in need of rehabilitation of their missing teeth will be referred to Prosthodontics dept.
- Patients will undergo history and complete oral examination after informed consent (Annexure-B). On the basis of these information the patient will be selected for the study acc to exclusion and inclusion criteria.
- The patients will then categorized into three groups based on clinical and radiographic features of ridges according to Wical-Swoope classification.
- A well-constructed denture will be fabricated and all the post op complaints will be resolved.
- Three forms of denture adhesives will be used including powder, cream and strips for all three resorption classes as described by Wical-Swoope.
- A digital spring scale will be used to record the reading , All the measurements will be recorded in grams
- Retentive strength will be recorded first before application of the adhesives for baseline retention strength.
- Patient with denture in his mouth will be instructed to maintain max non-forced intercuspation for fives minutes. Atfer that with mouth opened and lower lip relaxed in order to avoid losing peripheral seal tip of the spring scale will be placed at the margin of denture in recess to lingual frenum. Traction forced will be then applied until denture is detached, the max retention force being recorded by sping scale. This procedure will be repeated thrice and mean value will be calculated.
- A second reading will be recorded after application of adhesive in similar manner
- Mean increase in denture retention strength will be calculated by subtracting denture retention strength without adhesive from denture retentive strength with adhesive for both study products
- The scores calculated will be filled in Performa (annexure-A)
- The obtained data will be then used to compare diff form of commercially availble denture adhesives (pastes, powder and cushion) for their mean increase in retention strength.
- Then patient will be instructed about how to apply denture adhesives (based on manufacturer' instructions)
- The patient will fill out two attributed questionnaires, before and 1 week after using the denture adhesive. In the questionnaire the satisfaction rating will be determined using valid questionnaires with seven evaluation items: general satisfaction, ability to speak, ease of cleaning, stability, retention, comfort and mastication performance (VAS? Likert scale?)
- The quantitative variable, age of the patients and retention strength was presented as mean+- SD. The qualitative varaible like sex was presented as frequency and percentages. T-test was used to determine the existence if difference of mean retention strength b/w the two form of denture adhesives.
- Data were analyzed using ANOVA and Chi-square tests in SPSS software version 25 software (SPSS version 25.0, SPSS Inc; Chicago, IL, USA) (P<.05)
The score calculated will be filled in the performa (Annexure-A)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Resorption of mandibular ridge | Experimental | Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl celluloseLoss of upto 1/3 of original vertical height |
| Moderate Resorption of mandibular ridge | Experimental | Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose2. Moderate Resorption: Loss of upto 1/3 to 2/3 of original vertical height |
| Severe Resorption of mandibular ridge | Experimental | Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose3. Severe Resorption: Loss of 2/3 or more of original vertical height |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- edentulous patient willing to undergo new complete denture treatments and willing to visit the clinic for denture adjustment as a recall patient
- Healing period of at least 2 months after extraction.
Key exclusion criteria (10 listed)
- Difficulty responding to questionnaire
- Use of metallic base denture
- Xerostomia
- Ill-fitting dentures
- Neuromuscular disorder
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 |
|---|---|---|
| polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose3 forms of denture adhesives from each brands are used to compare the retentive strength on highly resorbed ridges | Drug | Mild Resorption of mandibular ridge, Moderate Resorption of mandibular ridge, Severe Resorption of mandibular ridge |
Primary outcome
To assess the retentive strength of various adhesives on various types of residual ridges using Spring scale
Time frame: 1 year
To compare the retentive strengths of different form of commercially available dentures adhesives
1 secondary outcome
To evaluate the effect of various denture adhesives on efficiency of complete denture in patient with different alveolar ridges using a well structured questionnaire
Time frame: 1 year
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 Apr 2024.
- Derived from this study: PubMed 41767362Maqsood A, Shahidan WNS, Abbasi MS, Salahuddin A, Das G, Ahmed N, Heboyan A. Subjective Evaluation of Denture Adhesives in Mandibular Complete Denture Patients: A Randomized Controlled Trial. Health Sci Rep. 2026 Feb 25;9(3):e71897. doi: 10.1002/hsr2.71897. eCollection 2026 Mar.
- Derived from this study: PubMed 40127129Ahmed N, Abbasi MS, Salahuddin A, Tariq L, Siraj S, Das G, Suleman G, Vohra F, Heboyan A. Comparative Analysis of Adhesive Retention and Denture Weight in Different Residual Ridge Morphologies: A Cross-Over Randomized-Controlled Trial. Clin Exp Dent Res. 2025 Feb;11(1):e70118. doi: 10.1002/cre2.70118.
- Individual participant dataSharing planned: No
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 Phase 1 study testing polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose in people with Retentive Strength of Denture Adhesives, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
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 2 inclusion and 10 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 Apr 2024. 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To assess the retentive strength of various adhesives on various types of residual ridges using Spring scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063422, which also lists 2 linked publications.
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 Apr 2024.