Comparison Between Acrylic and Soft Liner Telescopic Overdentures Regarding Patient Satisfaction
Patient Satisfaction of Soft Liner Versus Acrylic Resin Telescopes in Complete Overdenture Patients With Ectodermal Dysplasia: Non-Randomized Clinical Trial
1 other identifier
interventional
6
0 countries
N/A
Brief Summary
Conventional complete overdenture will be made to ectodermal dysplasia patients, a week after delivery and after 3 months Patient satisfaction, retention and periodontal condition will be assessed. the denture will be taken from the patient for 2 weeks.Acrylic telescopes will be replaced with soft liner and again Patient satisfaction, retention and periodontal condition will be assessed a week after delivery and 3 months later.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedApril 25, 2017
April 1, 2017
3 months
April 13, 2017
April 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Satisfaction
A questionaire will be given to the patient to assess thier denture satisfaction in numerical data using Visual Analogue Scale
3 months
Secondary Outcomes (5)
Retention
3 months
Gingival index
3 months
Probing depth
3 months
Tooth mobility
3 months
Absence or presence of inflammation
3 months
Interventions
Soft liner telescopes: Overdenture will be adjusted by relieving acrylic opposite to the abutment about 2 mm using a metal stone. The relieved areas will be painted with an adhesive and the rest of the fitting surface of the denture will be painted with a separating medium. The soft liner (Silicone based soft liner, mollosil, chairside soft relining-long term, DETAX, Germany) will then be applied in the relieved areas to act as a secondary coping The base and catalyst will be mixed according to the manufacturer's instructions on a glass slab. The mix will be placed on the relieved area, seated in the patient's mouth, the patient is asked to bite in centric relation and the excess liner is removed with a lancet.
Eligibility Criteria
You may qualify if:
- Partially edentulous ectodermal dysplasia patients with few remaining teeth.
- Cooperative patients with no history of psychological diseases.
- Length of maxillary remaining teeth should not be less than 4mm.
You may not qualify if:
- \- 1- Patients with tempo-mandibular joint disorders or systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- Patients allergic to acrylic resin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 25, 2017
Study Start
May 1, 2017
Primary Completion
August 1, 2017
Study Completion
November 1, 2017
Last Updated
April 25, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share