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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201307000557125 Date registered: 2013/06/06
TRIAL DESCRIPTION
Public title The Effect of Melatonin on Osseointegration Of immediate Loading Implant supported Mandibular Overdentures
Official scientific title The Effect of Melatonin on Osseointegration Of immediate Loading Implant supported Mandibular Overdentures
Brief summary describing the background
and objectives of the trial
Since the 1970s, osseointegrated dental implants have offered an alternative. They are surgically inserted into the jawbones to support a dental prosthesis and are retained because of the intimacy of bone growth onto the implant surface (osseointegration). Dental implants have undoubtedly been one of the most significant scientific breakthroughs in dentistry over the past 30 years(Marco E ,et.al 2007)Primary stability and the prevention of immediate loading implant movements may be important to allow osseointegration,implant survival and to improve the patient¿s oral health-related quality of life. (Adrian .et,al 2012). local administration of melatonin and on osseointegration of a dental implant increase bone apposition rate around dental implants and to accelerate the bone healing. (Fernando et,al 2012) .But little studies are done on the effect of the melatonin on bone healing in implant replacement which is the purpose of the present study. The aim of this study is to assess the effect of local melatonin administration on bone density around immediate loaded implant supported Overdentures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2013-10-01
Actual trial start date 2013-10-01
Anticipated date of last follow up 2014-10-01
Actual date of last follow up 2014-10-01
Anticipated target sample size (number of participants) 16   
Actual target sample size (number of participants) 16   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID
nil known This title is registrated in PACTR registery

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 using computer software program sealed opaque envelope Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group topical application of melatonin in the implant site 3 mg 1 year topical application of melatonin 8
Control group No melatonin application saline in the same volume 1 year No melatonin application in the other implant site of the same patient 8 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1.Completely edentoulous patient 2. sufficient inter arch space(14mm-18mm 3. All patients had normal maxillo-mandibular relationship (Class I Angle classification) 4.All patients were physically and psychologically able to tolerate conventional implant surgical protocol. 1.Patients with diabetes that may affect bone resorption 2. Pregnancy. 3.Presence of acute and active infection or inflammation in areas intended for implant placement. 40 Years 60 Years 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
Yes 2013/06/04 ethics commitee
Ethics Committee Address
Street address City Postal code Country
1 el saraya street-el manial cairo 12111 Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome measuring bone density day 0,1month,3 month, 6month,1 year
Secondary Outcome implant stability Day 0, 1 month, 3 month, 6 month. ,1 year

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of prothesis departement 1 el saraya street-el manial - cairo cairo 12111 Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty Of Oral and Dental Medicine,Cairo.Egypt 1 el manial street .Cairo Cairo 12111 Egypt
Faculty Of Oral and Dental Medicine,Cairo.Egypt 1 el manial street .Cairo Cairo 12111 Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of oral and d 1 el saraya street-el manial - cairo cairo 12111 Egypt University
Primary Sponsor faculty of oral and dental medicine Cairo university,egypt 1 el saraya street-el manial - cairo cairo 12111 Egypt University

COLLABORATORS
Name Street address City Postal code Country
faculty of oral and dental medicine ,cairo universty 1 el saraya street-el manial - cairo cairo 12111 Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Prof Alaa Aboul Ela dr_alaa_aboulela@ hotmail.com 01222151949
Street address City Postal code Country Position / Affiliation
Faculty of Oral and Dental Medicine, 1 saraya elmanial st. Cairo 12111 Egypt Professor of Prothodontics
Role Name Email Phone Fax
Scientific Enquiries Dr Mohamed Abdalla mfaroukabdulla@yahoo.com 01006781407
Street address City Postal code Country Position / Affiliation
Faculty of Oral and Dental Medicine, 1 saraya elmanial st. Cairo 12111 Egypt Lecturer of prothodontics
Role Name Email Phone Fax
Principal Investigator Dr Doaa Heshmat smily_teeth@hotmail.com 01006455491
Street address City Postal code Country Position / Affiliation
3055 el maadi,cairo cairo 1111 Egypt assisant lecturer