Trial no.:	PACTR201603000652225	Date of Approval:	21/09/2013
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Implant retained overdenture

Official scientific title

The Effect of Using Thermo-plastic Acrylic Denture Base versus Conventional Acrylic Denture Base on The Supporting Structures in Implant Retained Mandibular Over-denture: A Randomized Clinical Trial

Brief summary describing the background and objectives of the trial

This study is conducted to Compare the effect of using the thermo-plastic acrylic denture base versus using the conventional acrylic denture base on the supporting structures in implant retained mandibular overdenture.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

,Oral Health

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Devices

Anticipated trial start date

01/01/2014

Actual trial start date

01/01/2014

Anticipated date of last follow up

30/09/2014

Actual Last follow-up date

Anticipated target sample size (number of participants)

0

Actual target sample size (number of participants)

12

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Each participant will be randomly assigned following simple randomization procedure by using closed white envelops (12 closed white envelopes) which assign the group to be followed. Those closed envelops includes 6 paper charts (fig. 1) and 6 paper charts (fig. 2), which are folded three times not to show its contents to assure random assignment.	Simple randomisation using by using procedures such as coin-tossing or dice-rolling	Masking/blinding used
Parallel: different groups receive different interventions at same time during study	Randomised	Each participant will be randomly assigned following simple randomization procedure by using closed white envelops (12 closed white envelopes) which assign the group to be followed. Those closed envelops includes 6 paper charts (fig. 1) and 6 paper charts (fig. 2), which are folded three times not to show its contents to assure random assignment.	Simple randomisation using by using procedures such as coin-tossing or dice-rolling	Masking/blinding used	Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Thermoplastic acrylic denture base material" Versacryl"			thermoplastic denture base material	6
Control Group	Conventional acrylic denture base				6	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
¿ Patients are free from any medical, physical or mental handicapping condition. ¿ Ages range from 45-60 years. ¿ Completely edentulous and accept to wear implant overdenture.	Any known sensitivity or adverse reactions to the methaymethacrylate .		45 Year(s)	60 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

No

01/08/2013

Post graduate ethics committee

Ethics Committee Address
Street address	City	Postal code	Country
cairo university,Manyal -Giza	cairo	002	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	1ry outcome: Patient satisfaction Questionnaire Scores	M3 M6 M9
Secondary Outcome	Bone height around miniimplat, device	M3 M6 M9

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Cairo Univesity	Manyal - Giza	Cairo	002	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
self funding	27 Ismael Helmy st, Smouha	Alexandria	002 03	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Cairo University	Manyal - Giza	Cairo	002	Egypt	University
Primary Sponsor	Evidence Based Committee	Cairo University, dental school, Manyal -Giza	Cairo	002	Egypt	University
Primary Sponsor	Prosthesis department	Cairo uinversity, dental school, Manyal-Giza	Cairo	002	Egypt	University
Secondary Sponsor	Research committee	Cairo university, dental school, Manyal -Giza	Cairo	002	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Alaa Aboul Ela		Cairo	002	Egypt
Mahmoud Salloum	17 Ahmed Sedeek st, Sidi Gaber	Alexandria	002 03	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Miran Sultan	miran_sultan@hotmail.com	002 012 27550596	27 Ismael Helmy st, Smouha
City	Postal code	Country	Position/Affiliation
Alexandria	002 03	Egypt	Researcher
Role	Name	Email	Phone	Street address
Public Enquiries	Mahmoud Salloum	mahmoud.salloum@pua.edu.eg	002 010 01633507	17 Ahmed Sedeek st, Sidigaber
City	Postal code	Country	Position/Affiliation
Alexandria	002 03	Egypt	Lecturer at prosthodontic department
Role	Name	Email	Phone	Street address
Scientific Enquiries	Alaa Aboul ela	dr_alaa_aboulela@hotmail.com	002 01222151949	Faculty of dentistry, Cairo university. Manyal ,Giza
City	Postal code	Country	Position/Affiliation
Cairo	002	Egypt	professor at prosthodontic department

REPORTING
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URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date

Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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