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Trial registered on ANZCTR


Registration number
ACTRN12616001087448
Ethics application status
Approved
Date submitted
24/06/2016
Date registered
11/08/2016
Date last updated
11/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a topical anesthetic gel work better than infiltration anesthesia for ultrasonic scaling procedures? A split mouth, double blinded randomised controlled trial.
Scientific title
Does a topical anesthetic gel work better than infiltration anesthesia for ultrasonic scaling procedures? A split mouth, double blinded randomised controlled trial.
Secondary ID [1] 289508 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peridontitis 299209 0
Gingivitis 299485 0
Condition category
Condition code
Oral and Gastrointestinal 299218 299218 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 299383 299383 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a split mouth study. An independent researcher "I" makes random allocation
cards using computer-generated random numbers. He keeps the original random allocation sequences in an inaccessible third place and works with a copy. He will open the envelop for every patient at start of treatment and will tell dr A that which quadrant gets which form of intervention.
. 1.7 gram of 5 % lidocaine and prilocaine gel will be applied by dental surgeon in form of the topical dental cartridge which will applied with 23 guage blunt tipped applicator in the three teeth (central incisor, lateral incisor and canine). the quadrant will be chosen by computer generated random allocation by dr I. This dose will be spread between the specified teeth in quadrant.
Lidocaine infiltration anesthesia will be given in the central incisor, lateral incisor and canine ( the quadrant will be chosen by computer generated random allocation by dr I)..1.8 ml cartridge of 2% lidocaine with 1:100,000 epinephrine will be spread in specified teeth in form of infiltration by dental surgeon. Only single dose of both above anesthetics will be given to one patient.
The central incisor, lateral incisor and canine of two quadrants will serve as a control with saline wash given in both of them( the quadrant will be chosen by computer generated random allocation by dr I)
After local anesthesia has been given to the patients by Dr A, Dr B and Dr C will perform the ultrasonic scaling procedures. Both Dr B and Dr C will be blinded to the control and anesthesia quadrants.Dr A will check the time taken for the anesthesia to be effective with the blunt end of perisoteal elevator. After every 30 seconds the time will be noted for all four quadrants. The Dr X (who is also blind to the anesthetic applied in all quadrants) will ask the patient about the pain levels using a Visual Analogue Scale (VAS) calibrated from 1 to 10 at the start of treatment and at the end of treatment.
Both of the anesthesia will be given simultaneously. The anesthetic gel is effective for 20 minutes and infiltration for 40 minutes. During the procedure doctor Z will be observing the patient according to SEM scale which is sound eyes and motor scale
Intervention code [1] 295096 0
Treatment: Drugs
Comparator / control treatment
Saline wash will be given in central incisor, lateral incisor and canine ( the quadrant will be chosen by computer generated random allocation by dr I)
Control group
Placebo

Outcomes
Primary outcome [1] 298694 0
Proportion of participants with a reduction in pain scores using visual analogue scale
Timepoint [1] 298694 0
one hour after the commencement of intervention
Secondary outcome [1] 324983 0
Difference in time taken for topical and infiltration anaesthesia to be effective, assessed by the dental surgeon checking the time taken by anesthetic to be effective with the blunt end of the perisoteal elevator and writing in the study log
Timepoint [1] 324983 0
Every 30 seconds from application of anaesthesia to time of no sensation in upper and lower right and left central incisor, lateral incisor and canine with blunt end of perisoteal elevator

Eligibility
Key inclusion criteria
1. All participants must require ultrasonic scaling in all four mouth quadrants .
2. Patients who have not undergone any periodontal therapy in the past 12 months
3. Patients having a minimum of two incisors, one canine, one premolar and one molar in each quadrant
4. Patients between the ages of 20 and 60 years
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patients requiring prophylactic antibiotics before periodontal probing
(2) Patients suffering from any mental disorders or with any chronic pain problems
(3) Patients suffering with coagulation/bleeding disorders or on anticoagulants
(4) Pregnant or lactating women
(5) Patients with congenital or idiopathic methemoglobinemia
(6) Patients reporting hypersensitivity to lidocaine/benzocaine
(7) Patients taking nonsteroidal anti-inflammatory drugs in the 3 days before participation in the study and
(8) Patients having acute periodontal pain, pulpitis, abscesses, or other acute infections.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
vas scale
sem scale will be used to assess outcomes
The sample size was calculated using the repeated measures ANOVA design . A VAS variance as reported for anesthetics was 3 and for intergroup variance was 14. Errors were set as alpha =0.05 and beta=0.2. A total sample size was determined to be 20 patients in order to compensate for possible dropouts . The level for statistical significance is 0.05

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 7977 0
Pakistan
State/province [1] 7977 0
Islamabad

Funding & Sponsors
Funding source category [1] 293879 0
University
Name [1] 293879 0
Riphah Academy of Research and Education
Country [1] 293879 0
Pakistan
Primary sponsor type
Individual
Name
Humza Bin Saeed
Address
Islamic International Dental College, 7TH Avenue, G-7/4, Islamabad, Pakistan
Country
Pakistan
Secondary sponsor category [1] 292714 0
Individual
Name [1] 292714 0
Kinza Ayub
Address [1] 292714 0
Islamic International Dental College, 7TH Avenue, G-7/4, Islamabad, Pakistan
Country [1] 292714 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295307 0
Islamic International Dental College Research Ethics Committee
Ethics committee address [1] 295307 0
Ethics committee country [1] 295307 0
Pakistan
Date submitted for ethics approval [1] 295307 0
15/05/2016
Approval date [1] 295307 0
14/06/2016
Ethics approval number [1] 295307 0
IIDC/IRC/2016/06/003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66426 0
Dr Humza Bin Saeed
Address 66426 0
Islamic International Dental College, 7TH Avenue, G-7/4, Islamabad, Pakistan
Country 66426 0
Pakistan
Phone 66426 0
+92512891835
Fax 66426 0
Email 66426 0
Humza.saeed@riphah.edu.pk
Contact person for public queries
Name 66427 0
Humza Saeed
Address 66427 0
Islamic International Dental College, 7TH Avenue, G-7/4, Islamabad, Pakistan
Country 66427 0
Pakistan
Phone 66427 0
+92512891835
Fax 66427 0
Email 66427 0
Humza.saeed@riphah.edu.pk
Contact person for scientific queries
Name 66428 0
Humza Saeed
Address 66428 0
Islamic International Dental College, 7TH Avenue, G-7/4, Islamabad, Pakistan
Country 66428 0
Pakistan
Phone 66428 0
92512891835
Fax 66428 0
Email 66428 0
Humza.saeed@riphah.edu.pk

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.