Does a topical anesthetic gel work better than infiltration anesthesia for ultrasonic scaling procedures? A split mouth, double blinded randomised controlled trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001087448
• Date of registration: 11/08/2016
• Prospective Registration: Yes
• Primary sponsor: Humza Bin Saeed
• 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.
• Date of first enrolment: 01/09/2016
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616001087448.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Type of endpoint: Efficacy;

Countries of recruitment

Pakistan

Contacts

• Name: Dr Humza Saeed

• Name: Dr Humza Saeed

Key inclusion & exclusion criteria

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

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.



Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

peridontitis;Gingivitis ;
peridontitis
Gingivitis

Anaesthesiology - Anaesthetics

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention(s)

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 anesthe

Primary Outcome(s)

Proportion of participants with a reduction in pain scores using visual analogue scale [one hour after the commencement of intervention]

Secondary Outcome(s)

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[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]

Secondary ID(s)

nil known

Source(s) of Monetary Support

Riphah Academy of Research and Education

Secondary Sponsor(s)

Kinza Ayub

Ethics review

Status: Approved
Approval date:
Contact:

Islamic International Dental College Research Ethics Committee