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.: PACTR201804003153395 Date of Approval: 27/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title In situ evaluation of dentinal tubule occlusion of Hydroxyapatite-containing toothpaste or calcium sodium phosphosilicate-containing toothpaste for tr
Official scientific title In situ evaluation of dentinal tubule occlusion of Hydroxyapatite-containing toothpaste or calcium sodium phosphosilicate-containing toothpaste for treatment of dentin hypersensitivity
Brief summary describing the background and objectives of the trial Dentin hypersensitivity is characterized by distinctive short, sharp pain arising from the exposed dentin in response to various stimuli(West et al., 2013). The etiology of dentin hypersensitivity is not fully understood, This lack of knowledge makes the management of dentin hypersensitivity difficult (Kawasaki et al., 2001). When comparing areas of sensitive to those of non sensitive clinically exposed cervical dentin, hypersensitive teeth exhibited open dentinal tubules on the surface. (Absi et al., 1987). Present approaches to treat dentin hypersensitivity employed agents that either chemically suppress or modify the nerve impulse by direct neurological interaction or mechanically occlude the dentin tubules( Schmidlin et al., 2013), thus reducing hypersensitivity pain (Amaechi, Mathews, & Mensinkai, 2014). Currently hydroxyapatite-conatining toothpaste is available (Aykut-Yetkiner, Attin, & Wiegand, 2014) and could be a solution to treat dentin hypersensitivity. We specifically want to determine whether hydroxyapatite-containing toothpaste could block the dentinal tubules to provide an effective treatment for dentin hypersensitivity compared to calcium sodium phosphosilicate toothpaste and whether their blocking action could be retained in the oral environmental conditions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) In situ study
Disease(s) or condition(s) being studied dentin hypersensitivity,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2018
Actual trial start date
Anticipated date of last follow up 01/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status Recruiting
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 simple randomisation using a randomisation table created by a cpmputer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group hydroxyapatite-containing tooth paste twice daily eight weeks hydroxyapatite-containing tooth paste 21
Control Group calcium sodium phosphosilicate containing tooth paste calcium sodium phosphosilicate containing tooth paste 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Patients with age ¿ 18 years. 2-Patients having good general and oral health 3-Patients without known allergy to any commercial dental products 4- Patients with at least 18 healthy teeth exposed to the oral enviroment 5- Patients having normal salivary function. 6-No evidence of significant oral soft tissue pathology 1- Patients with periodontal disease requiring aggressive treatment 2-Lactating and pregnant females 18 Year(s) 80 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 13/07/2017 Cairo University-Faculty of Oral and Dental Mdicine-Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
12 SarayaEl Manial st,Kasr El Ainy cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome dentinal tubule occlusion baseline 24 hours 6 weeks 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of oral and dental medicine, Cairo university 12 Saray El Manial st, Kasr El Ainy Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Oral and Dental Medicine,Cairo university 12 Saray El Manial st, Kasr El Ainy Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine,Cairo university 12 Saray El Manial st, Kasr El Ainy Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdelwahed 14th-109 Buildings-6th district Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba Helal hebahelal@gmail.com +202 1001847077 119 Masr Helwan Agriculture Road, Maadi
City Postal code Country Position/Affiliation
cairo Egypt
Role Name Email Phone Street address
Public Enquiries Heba El Deeb heba.eldeeb@dentistry.cu.edu.eg +202 1066109461 12 El Saraya El Manial, Kasr El Ainy
City Postal code Country Position/Affiliation
cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries heba helal hebahelal@gmail.com +2021001847077 119 Masr Helwan Agriculter road, Maadi
City Postal code Country Position/Affiliation
cairo Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information