Effect of Denture Adhesives on Complete Denture Patients

NCT05496283 | Completed

• 1 other identifier: NSEreifej
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of using denture adhesives on patient satisfaction with complete dentures; A randomized clinical trial. The study evaluates the effect of using 3 types of denture adhesives on patient satisfaction and quality of life of complete denture patients

Conditions

Complete Edentulism

Keywords

Complete dentures; Patient satisfaction; denture adhesives

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction form

  10 aspects regarding patient satisfaction with dentures on 100mm visual analogue scale, with 0 value being completely unsatisfied and 100 for completely satisfied

  1 month after denture delivery

• oral health impact profile for edentulous patients (OHIP-EDENT)

  20 aspects linking the dentures with patient quality of life, with a range of values from 1 to five for each aspect, with 1 being the best and 5 being the worst.

  I month after denture delivery

Study Arms (3)

Corega

EXPERIMENTAL

Complete denture patients given Corega denture adhesive.

Other: denture adhesive

OlivaFix

EXPERIMENTAL

Complete denture patients given OlivaFix denture adhesive.

Other: denture adhesive

Sea.Bond

EXPERIMENTAL

Complete denture patients given Sea.Bond denture adhesive.

Other: denture adhesive

Interventions

denture adhesive OTHER

After 1 month of using the complete denture with no denture adhesives, patients fill up satisfaction and quality of life forms and given 1 of 3 types of denture adhesive to use for month to compare satisfaction and quality of life forms

Corega; OlivaFix; Sea.Bond

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seeking new conventional complete dentures for first time
• Patients aged 40-85 years
• Must be completely edentulous for at least 6 months
• Must have well-developed to moderately resorbed maxillary and mandibular ridges
• Must have no denture fissuratum or any traumas from previous dentures
• Must be able to complete and sign the consent form

You may not qualify if:

• Patients with relevant medical issues, disorders of masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect response to treatment
• Patients with oral pathology, xerostomia, or tied tongue condition.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

The University of Jordan

Amman, 11942, Jordan

Location

Related Publications (1)

• Ereifej NS, Oweis YG, Abu-Awwad M. The effect of using denture adhesives on patient satisfaction with complete dentures; a randomized clinical trial. BMC Oral Health. 2023 Dec 19;23(1):1027. doi: 10.1186/s12903-023-03757-7.

  PMID: 38114958 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Dental Cements

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Nadia Ereifej, PhD

  The University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 11, 2022
• Study Start: February 10, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 28, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)