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.: PACTR201906464023194 Date of Approval: 24/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect Of a Self-etch Adhesive Containing Nanobioglass On Postoperative Sensitivity Of Posterior Composite Restorations. A Randomized Trial
Official scientific title Effect Of a Self-etch Adhesive Containing Nanobioglass On Postoperative Sensitivity Of Posterior Composite Restorations. A Randomized Trial
Brief summary describing the background and objectives of the trial Despite recent developments in dental restorative materials and techniques, postoperative sensitivity following posterior composite restorations is still a commonly reported problem among dentists. This problem could be related to cavity preparation trauma, polymerization shrinkage of resin composites which may, in turn, lead to internal stresses, debonding, gap formation and leakage of bacteria through the tooth restoration interface. Recently, the solution to this problem has been related to dentin adhesives’ ability to seal the gaps and open dentinal tubules that are present between the adhesive and the dentin. In this regard, the current study tested the ability of a nanobioglass containing versus a nanobioglass free self-etch adhesive on the reduction of postoperative sensitivity of class II composite restorations.
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: Other
Anticipated trial start date 15/06/2015
Actual trial start date 15/01/2016
Anticipated date of last follow up 15/01/2017
Actual Last follow-up date 01/02/2017
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 16
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Single step self etch adhesive without nanobioglass. 3 Months The nanobioglass powder was not added to the whole bottle of the single step self etch adhesive in the control group. This single step self etch adhesive that does not contain nanobioglass was placed in teeth having moderately to deep sized class II cavities that are indicated for resin composite restorations. Postoperative sensitivity was evaluated at 1 day, 1 week, 1 month, 3 months by instructing the patients to mark their sensitivity levels using a visual analog scale. 8 Active-Treatment of Control Group
Experimental Group Single step self etch adhesive containing nanobioglass 3 Months The nanobioglass powder was added to the whole bottle of the single step self etch adhesive in the control group. This single step self etch adhesive that contains nanobioglass was placed in teeth having moderately to deep sized class II cavities that are indicated for resin composite restorations. Postoperative sensitivity was evaluated at 1 day, 1 week, 1 month, 3 months by instructing the patients to mark their sensitivity levels using a visual analog scale. 8
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Moderate to deep proximal primary carious lesions in posterior teeth. Patients showing no signs of spontaneous dental or orofacial pain. Selected teeth should not have any signs or symptoms of pulpal and periapical disease. Selected teeth should have an occlusal contact with natural or crowned antagonist teeth so that it could be tested for post-operative pain during chewing of food. Previously restored teeth showing secondary caries. Defective restorations that need a replacement for esthetic reasons. Occlusal disturbances or temporo-mandibular joint problems involving gingival recession or alveolar bone loss. Patients taking analgesics that could alter their normal pain perception level. Patients on orthodontic treatment. Medical, psychiatric, or pharmaco-therapeutic histories that might compromise the study protocol including chronic use of anti-inflammatory, analgesic, psychotropic drugs. Abutment teeth for a fixed or removable prosthesis. Pregnancy or breastfeeding, acute and chronic systemic diseases, immune-compromised patients. Medical problems preventing the participant from showing up to return the Visual Analog Scale (VAS) in its due time. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 52 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 15/02/2015 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
11 Elsaraya Street, Manial, Cairo cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative sensitivity after class II resin composite restorations. 1 Day, 1 week, 1 Month, 3 Months.
Secondary Outcome Effect of cavity depths on levels of postoperative sensitivity after class II resin composite restorations. 1 day, 1 week, 1 Month, 3 Months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Operative Dentistry department Faculty of Oral and Dental Medicine Cairo University. 11 Elsaraya street, Manial Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Zakaria 46 district E, hadabet el haram. Giza 12555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty Of Oral and Dental Medicine Cairo University. 11 Elsaraya Street, Manial Cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Riad 11 Elsaraya street, Manial Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Zakaria ahmedzakaria1981@gmail.com 00201226652267 Batal El Salam Street, Albahary
City Postal code Country Position/Affiliation
Fayoum Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Mona Riad monariad50@hotmail.com 00201006608683 11 Elsaraya Street, Manial
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Conservative Dentistry Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mona Riad monariad50@hotmail.com 00201006608683 11 Elsaraya Street, Manial
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Conservative Dentistry Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I plan to share all data and documents related to the study. This includes raw data of the results, Data of the readings obtained from all the tests and investigations that are used in the study. I also plan to share all the data of patients who participated that is related to the outcomes of the study. In addition to all the data of the materials used. Informed Consent Form There is no time frame for IPD sharing because all data related to the study are already available for sharing as the study was completed in 2017. -Data of this study are available via controlled access. -Any researcher or a qualified research group who did not participate in the trial are eligible to request IPD. -The data requester should provide a brief description of his/her research project including title, Background, Objectives, and endpoints. - Requests for IPD are made via e-mail: ahmedzakaria1981@gmail.com - The principal investigator and the collaborator are responsible for reviewing and making decisions regarding IPD requests. - Estimated length of time to reach a decision about a data request is 1 week, additional time may be required to prepare and release the data. - Following approval of the data request, the process of data release will be done by direct upload of the datasets to the data recipient's e-mail.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The nanobioglass containing self-etch adhesives scored a significantly lower postoperative sensitivity ratings than the nanobioglass free one (P< 0.05). The nanobioglass containing self-etch adhesive had a significantly lower postoperative sensitivity scores than the nanobioglass free one at the 1 day and the 1 week evaluation periods, while at the 1 months and 3 months evaluation periods, both materials did not possess any significant difference. Thus the problem of postoperative sensitivity after resin composite restorations could be solved by the addition of bioglass nanoparticles into dental adhesives. 26/04/2019 26/04/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks dx.doi.org/10.17504/protocols.io.2csgawe
Changes to trial information