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.: PACTR202204787113528 Date of Approval: 14/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON BETWEEN THE EFFECTS OF LOW-LEVEL LASER THERAPY AND CRYOTHERAPY ON POST-ENDODONTIC PAIN
Official scientific title COMPARISON BETWEEN THE EFFECTS OF LOW-LEVEL LASER THERAPY AND CRYOTHERAPY ON POST-ENDODONTIC PAIN - A RANDOMISED CONTROLLED CLINICAL TRIAL
Brief summary describing the background and objectives of the trial Pain is a common reason why individuals seek health care because it affects their physical, emotional, mental, social and financial life. The major cause of pain in the dental setting is dental caries, which is reported to be the most prevalent among 345 diseases globally. The treatment of choice for untreated dental caries is Root Canal Treatment (RCT). Unfortunately, post-operative pain is often experienced following RCT with peri-apical inflammation as the major cause. This is a cause of concern both for the Dentist and the Patients. Hence the reason for revision of inflammatory processes and pain control, with a focus on NSAIDs and corticosteroids. To mitigate the side effects of these drugs, non-pharmacologic treatment adjuncts like Cryotherapy and Low-Level Laser therapy are being studied. To the best of our scientific research in English literature, only a very few studies have compared these two treatment adjuncts. OBJECTIVES 1. To determine over one week, the level of post-endodontic pain in each of the experimental groups (Cryotherapy and LLLT) and the control group, using the Visual Analogue Scale ( VAS) 2. To compare the level of post-endodontic pain in each of the experimental groups (Cryotherapy and LLLT) and the control group over a one-week period using the VAS 3. To determine the level of post-endodontic tenderness to percussion on the 7th day, in each of the experimental groups (Cryotherapy and LLLT) and the control group using the VAS 4. To compare the level of tenderness to percussion on the 7th day, in each of the Experimental groups (Cryotherapy and LLLT) and the Control group using the VAS
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 09/05/2022
Actual trial start date 23/05/2022
Anticipated date of last follow up 18/11/2022
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low level laser 0.8Watts Power, 36Joules of Energy, and 980nm wavelength of low-level laser light directed towards each tooth apex buccally and lingually/palatally 2 to 3 times depending on the tooth type 40 - 60 seconds in 2 to 3 divided doses (20 seconds each) depending on the tooth type. After Obturation, the low-level laser light was directed 10mm away from the buccal and lingual mucosa related to the apices of the tooth being treated for about 20 seconds each 35
Experimental Group Cryotherapy 5ml of cold saline (2.5 degrees centigrade) in each root canal 5 minutes During the root canal treatment, the root canals were cleaned, shaped and irrigated at the same time with sodium hypochlorite, followed by EDTA, and the final irrigation was carried out using 5mls of 2.5 degrees centigrade (cold) normal saline, for 5minutes, then the canals were obturated 35
Control Group Root Canal Treatment without any adjunct Paracetamol tablet 1000mg 8 hourly OR Ibuprofen tablet 400mg 12 hourly If postoperative pain was unbearable 3days After the root canal treatment, the 35patient was given a prescription of analgesics/NSAIDs to take if he or she felt unbearable pain after the treatment 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Subjects who are willing to give informed consent and abide by the protocol of the research • Well-motivated subjects • Permanent teeth (except third molars) with matured apex • Carious permanent teeth (except third molars) with symptoms of irreversible pulpitis • Carious permanent teeth (except third molars) with acute apical periodontitis characterised by tenderness to percussion clinically. Radiographically, normal periodontal ligament space and lamina dura • Carious permanent teeth (except third molars) with acute apical periodontitis characterised by tenderness to percussion clinically. Radiographically, loss of lamina dura around the apex and periodontal ligament space widening • Carious permanent teeth (except third molars) with acute apical periodontitis characterised by tenderness to percussion clinically. Radiographically, small sized periapical radiolucency and loss of lamina dura. • Symptomatic carious permanent teeth (except third molars) requiring single-visit root canal treatment • Subjects that are chronically ill and cannot tolerate a long dental procedure • Subjects with poorly controlled systemic conditions like poorly-controlled hypertension or diabetes • Pregnant females • Uncooperative patients • Patients with poor oral hygiene that cannot be improved within a limited time • Teeth with insufficient periodontal support • Teeth that cannot be restored to function • Subjects who have taken antibiotics within 3 days before treatment commences • Teeth requiring Root Canal Re-treatment • Teeth with weeping canals • Teeth with severely curved roots • Teeth with difficulty in determining the working length • Patients with complications during treatment such as broken files, over-instrumentation, overfilling, or incomplete filling • Permanent teeth with clinical and radiographical anomalies and anatomical variations Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 76 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 27/09/2021 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 107, 1st Floor, LUTH Administrative Building Lagos 12003 Nigeria
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 12/05/2023 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi-araba, Surulere Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-operative pain reduction 1 - 7 days
Secondary Outcome Post-operative tenderness to percussion Day 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi-araba, Surulere Lagos 100254 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ODUKOYA ALABI ADETOUN O Restorative Department, Faculty of Dental Sciences, Lagos University Teaching Hospital, Idi-Araba, Surulere Lagos 12003 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ODUKOYA ALABI ADETOUN OLUWAFEMI RESTORATIVE DEPARTMENT, FACULTY OF DENTAL SCIENCES, LAGOS UNIVERSITY TEACHING HOSPITAL, IDI ARABA SURULERE LAGOS 12003 Nigeria SELF
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ADETOUN ODUKOYA ALABI tounalabi@gmail.com +23408023104900 RESTORATIVE DENTISTRY DEPARTMENT, FACULTY OF DENTAL SCIENCES, LAGOS UNIVERSITY TEACHING HOSPITAL, SURULERE
City Postal code Country Position/Affiliation
LAGOS 12003 Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries Oluwatosin Makanjuola jomakanjuola@unilag.edu.ng +2348034096722 Restorative Department, Faculty of Dental Sciences, Lagos University Teaching Hospital, Surulere
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Senior Colleage
Role Name Email Phone Street address
Scientific Enquiries Olabisi Oderinu bisioderinu@yahoo.co.uk +2348023077654 Restorative Department, Faculty of Dental Sciences, Lagos University Teaching Hospital, Surulere
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries Cyril Adegbulugbe cyadegbulugbe@hotmail.com +2348033212085 Restorative Department, Faculty of Dental Sciences, Lagos University Teaching Hospital, Surulere
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de-identification (tables, figures and appendices Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Data will be available to anyone who wishes to access the data for any purpose Proposals should be directed to tounalabi@gmail.com. To gain access, data will need to sign a data access agreement. Data will be available for 5 years at a link that will be provided later
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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