None listed
Conditions
Brief summary
This study will aim to evaluate the efficacy of anesthetic gel in comparison to infiltration and saline (placebo) during the scaling procedure. Controlling the sensation of pain and the associated anxiety is of prime importance in the practice of dentistry. Dental pain and its associated anxiety has been identified as one of the two most important barriers to dental access. A range of treatments, including pharmacological and non-pharmcalogical interventions have been advocated for the management of pain and anxiety in dentistry.Periodontal diseases are amongst the most common reported dental ailments. Majority of people are reported to be suffering from some form of periodontal diseases. The most common management strategy adopted for mild to moderate periodontal diseases is ultrasonic scaling. Patients have reported undergoing varying levels of pain while undergoing scaling procedures. Several strategies have been reported in literature to manage pain associated with scaling. These include the use of infiltration and topical local anesthesia. More recently, a new non-injection anesthetic, lidocaine/prilocaine gel for scaling and root planning has also been introduced. Moreover, it has recently been demonstrated that a eutectic mixture of local anesthetics (EMLA) is more efficient than a lidocaine gel. There is varying evidence in literature comparing the efficacy of topical versus infiltration local anesthesia for scaling procedures. Our study aims to assess the clinical anesthetic efficacy of lidocaine and prilocaine topical gel versus lidocaine infiltration injection and saline (placebo) for the management of pain during scaling procedures in patients with mild to moderate periodontal disease.
Interventions
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 wh
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
Sponsors
Humza Bin Saeed
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Outcome results
None listed