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

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.

Study Overview

• Status: Unknown
• Conditions: Patient Satisfaction; Retention; Periodontal Health
• Intervention / Treatment: Other: Soft liner telescopes

Detailed Description

Upper and Lower Primary impressions will be carried out by using irreversible hydrocolloid (Alginate, Tropicalgin, Normal setting, Zhermack, Italy) according to manufacturer's instructions using stainless steel stock trays.

Secondary upper impression is done with an acrylic special tray. Border molding is done with putty consistency rubber base impression material, Final impression with medium consistency rubber-base impression material (Silicone impression material, Elite P&P, Regular Body-Normal set, Zhermack, Italy) Maxilla-mandibular relationship will be recorded using check bite technique. Setting of artificial teeth will be performed and trial dentures will be tried in inside patients' mouth.

The finished and polished dentures will be delivered immediately after the necessary occlusal adjustments and instructions regarding hygiene and maintenance.

The patient will use the upper overdenture for 3 months. The overdenture is taken from the patient for two weeks, after which the maxillary 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.

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Partially edentulous ectodermal dysplasia patients with few remaining teeth.
2. Cooperative patients with no history of psychological diseases.
3. Length of maxillary remaining teeth should not be less than 4mm.

Exclusion Criteria:

- 1- Patients with tempo-mandibular joint disorders or systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.

2- Patients allergic to acrylic resin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	Retention will be assessed subjectively using Kapur's retention scoring system in ordinal data.	3 months
Gingival index	periodontium condition will be assessed through Gingival index scoring system in ordinal data	3 months
Probing depth	Probing depth will be measured using periodontal probe in Mm	3 months
Tooth mobility	tooth mobility will be assessed through periostest using Periotest value.	3 months
Absence or presence of inflammation	Absence or presence of inflammation will be assessed visually as a binary outcome	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 23, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 23, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 171088

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