Retentive Strength of Denture Adhesives on Various RR Ridges

NCT05063422 | Completed Phase 1 DMC

• 1 other identifier: Denture adhesive
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retentive Strength of Denture Adhesives

Keywords

alveolar ridge resorption; denture adhesives

Outcome Measures

Primary Outcomes (1)

• 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

  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

  1 year

Study Arms (3)

Mild Resorption of mandibular ridge

EXPERIMENTAL

Loss of upto 1/3 of original vertical height

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

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

Drug: polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose

Interventions

polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose DRUG

3 forms of denture adhesives from each brands are used to compare the retentive strength on highly resorbed ridges

Mild Resorption of mandibular ridge; Moderate Resorption of mandibular ridge; Severe Resorption of mandibular ridge

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Altamash Institute of Dental Medicine: lead

Study Sites (1)

Altamash Institute of dental medicine

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (1)

• Ahmed 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.

  PMID: 40127129 DERIVED

MeSH Terms

Interventions

Carboxymethylcellulose Sodium

Intervention Hierarchy (Ancestors)

Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor (BDS, FCPS)

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: October 1, 2021
• Study Start: August 18, 2022
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)