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: pactr.samrc.ac.za
Trial no.: PACTR201307000557125 Date of Approval: 06/06/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
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 bone loss,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2013
Actual trial start date 01/10/2013
Anticipated date of last follow up 01/10/2014
Actual Last follow-up date 01/10/2014
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 16
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Care giver/Provider
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 Age Category Minimum age Maximum 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 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
Yes 04/06/2013 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 Street address
Principal Investigator Doaa Heshmat smily_teeth@hotmail.com 01006455491 3055 el maadi,cairo
City Postal code Country Position/Affiliation
cairo 1111 Egypt assisant lecturer
Role Name Email Phone Street address
Public Enquiries Alaa Aboul Ela dr_alaa_aboulela@hotmail.com 01222151949 Faculty of Oral and Dental Medicine, 1 saraya elmanial st.
City Postal code Country Position/Affiliation
Cairo 12111 Egypt Professor of Prothodontics
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdalla mfaroukabdulla@yahoo.com 01006781407 Faculty of Oral and Dental Medicine, 1 saraya elmanial st.
City Postal code Country Position/Affiliation
Cairo 12111 Egypt Lecturer of prothodontics
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information