Comparison Between Acrylic and Soft Liner Telescopic Overdentures Regarding Patient Satisfaction

Patient Satisfaction Clinical Trial

Official title:

Patient Satisfaction of Soft Liner Versus Acrylic Resin Telescopes in Complete Overdenture Patients With Ectodermal Dysplasia: Non-Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03127033
• Other study ID #: 171088
• Status: Not yet recruiting
• Phase: N/A
• First received: April 13, 2017
• Last updated: April 23, 2017
• Start date: May 1, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: April 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: November 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patient Satisfaction
• Periodontal Health
• Retention

Intervention

Other:
• Soft liner telescopes
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

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