Retentive Strength of Denture Adhesives on Various RR Ridges

April 8, 2024 updated by: Dr Maria Shakoor, Altamash Institute of Dental Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • Altamash institute of dental medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Difficulty responding to questionnaire
  • Use of metallic base denture
  • Xerostomia
  • Ill-fitting dentures
  • Neuromuscular disorder
  • Smoking habits
  • Debilitating diseases
  • Immunocompromised
  • Maxillofacial defects
  • Use a tissue conditioner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mild Resorption of mandibular ridge
Loss of upto 1/3 of original vertical height
Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose
3 forms of denture adhesives from each brands are used to compare the retentive strength on highly resorbed ridges
Experimental: Moderate Resorption of mandibular ridge
2. Moderate Resorption: Loss of upto 1/3 to 2/3 of original vertical height
Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose
3 forms of denture adhesives from each brands are used to compare the retentive strength on highly resorbed ridges
Experimental: Severe Resorption of mandibular ridge
3. Severe Resorption: Loss of 2/3 or more of original vertical height
Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose
3 forms of denture adhesives from each brands are used to compare the retentive strength on highly resorbed ridges

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
To evaluate the effect of various denture adhesives on efficiency of complete denture in patient with different alveolar ridges using a well structured questionnaire
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Altamash Institute of Dental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Denture adhesive

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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