Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04929522 |
| Other study ID # |
FDASU-REC IM061101 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
May 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Achieving profound anesthesia during endodontic treatment of mandibular molars with
symptomatic irreversible pulpitis is still a demanding clinical challenge. therefore, the
success Rate of 4 Injection protocols for Mandibular First Molars with Symptomatic
Irreversible Pulpitis was evaluated clinically in a randomized triple-blind trial
Description:
Trial design This study was a prospective, randomized, parallel, triple blinded, clinical
trial. The present trial design methodology conforms to the CONSORT guidelines for reporting
randomized clinical trials.Participants A sample size calculation was performed based on the
study by (Kanaa M, Whitworth JM, Meechan JG. A Prospective Randomized Trial of Different
Supplementary Local Anesthetic Techniques after Failure of Inferior Alveolar Nerve Block in
Patients with Irreversible Pulpitis in Mandibular Teeth. J Endod 2012;38:421-425). This
research was based on a type I error of 0.05 and a power of 0.8 and indicated that ideally a
sample size of 36 in each group would be required to detect a 20% difference in the success
rate of the test groups. To increase the validity of the study, 40 subjects in each group
were considered.Ethical considerations This trial was conducted with the approval of the
institutional review of board (IRB) of the ethics committee at the Faculty of Dentistry, Ain
Shams University, Cairo, Egypt (FDASU-REC 772019). Patients signed a printed informed consent
form after explanation of the treatment procedure and associated possible adverse effects of
the proposed interventions such as discomfort, pain, anesthetic failure and systemic side
effects at this stage. Randomization To ensure random selection, participants were allocated
randomly into four groups with1:1 allocation ratio by using computer generated randomization
(www.randome.org). The sequence was therefore generated.
Allocation concealment mechanism: The sequentially generated numbers were placed in opaque
envelopes until the intervention was conducted, and each participant was asked to select an
envelope that determines which group of intervention was assumed.
Implementation: Co-researcher used computer generated randomization for participants who
achieve eligibility criteria and accordingly participants were enrolled in either of the
groups under study.
Blinding Both the participants, the operator who initiated endodontic treatment and monitored
the pain, and the statistician were blinded to the anesthetic techniques used.
Intervention Diagnosis was confirmed through history reporting spontaneous pain, a moderate
to severe painful response that persists after thermal stimulation, a prolonged response to
cold testing with Endo-Ice (1,1,1,2 tetrafluoroethane; Hygenic Corp, Akron, OH), absence of
percussion sensitivity and the periapical aspect of the tooth in the bidimensional periapical
radiograph was normal. Matching vital contralateral teeth were also tested to ensure an
accurate diagnosis and to serve as controls. To prevent bias, this diagnostic step was
performed by one investigator (AH), while another investigator (DK) was responsible for
administration of all anesthetic injections (DK), and a third investigator (SS) was
responsible for root canal treatment procedures and pain recording. All investigators have a
minimum of 12 years of clinical experience in endodontics.
One hundred and eighty-five patients consecutively visited were assessed for eligibility.
Twenty-five patients were excluded for different reasons and the others (eighty-four female
and seventy-six male patients) were allocated to the trial (Figure 1) and randomly assigned
into 4 groups (n=40) as follows:
Group 1 (IANB): After determining the injection site and aspiration, 3.6ml of the anesthetic
solution was administered using the standard inferior alveolar nerve block (IANB), this was
considered the control group.
Group 2 (IANB + IO): A standard IANB was administered the same as for Group 1, followed by a
supplemental intraosseous infusion (IO) injection using the Anesto system (W&H Dentalwerk
Bürmoos, Austria). To ensure comfort during the procedure, 0.1ml of anesthetic solution was
infiltrated at the perforation site using the standard syringe. The perforation site was
selected near the junction of the attached and unattached gingival tissues, immediately
distal to the first molar. Perforation was accomplished by operating the Anesto handpiece at
full speed, with constant moderate pressure maintained until the perforator was felt to
'drop' into the cancellous bone. 1.8mL of the anesthetic solution was then deposited over a
60-second period. The Anesto handpiece was again retracted and, with the perforator rotating,
removed from the injection site.
Group 3 (IANB + PDL): A standard IANB was administered the same as for groups 1 and 3,
followed by a supplemental periodontal ligament (PDL) injection. The needle was wedged with
force into the PDL space between the tooth and the alveolar crest of the bone, at 30-degrees
to the long axis of the tooth. The thumb and index fingers of the left hand supported the
needle to prevent buckling. The handle of the syringe was squeezed firmly until backpressure
was achieved. Then a total of 1.8ml of the anesthetic solution were injected mesially and
distally to the treated molar.
Group 4 (IANB + BI): A standard IANB was administered the same as for groups 1, 2 and 3,
followed by a supplemental buccal infiltration at the buccal side of the affected tooth. A
total of 1.8ml of the anesthetic solution were injected halfway the mesiodistal width of the
clinical crown.
IANB, PDL and BI injections were performed with a conventional dental syringe (indicate the
brand) and a 27-G needle at a rate of 2 mL/min. The anesthetic solution used for all
techniques was Articaine HCL 4% with 1:100,000 adrenaline (Artinibsa, Inibsa, Barcelona,
Spain). The efficacy of anesthesia was determined by the following: (1) confirmation of lip
numbness, (2) negative response to Endo-Ice, (3) negative response to the maximum output of
the electric pulp tester (Parkell, Edgewood, NY, USA).
Root canal treatment procedure was later initiated, and the patients were asked to rate their
pain using a visual analogue scale (VAS). Pain was scored as follows: Score 0, no pain; Score
1, mild pain; Score 2, moderate pain; or Score 3, severe pain. After rubber dam placement and
during caries removal, access preparation and pulpectomy, success of the anesthetic technique
was determined by VAS. The technique was considered as a 'success' when the patient reported
no pain (VAS = 0 or 1) and as a 'failure' otherwise (VAS >1).
Heart rate changes were monitored with a finger pulse oximeter (Medlinket, Shenzhen Med-link
Electronics, Shenzhen, China). It was recorded from 2 min before to 5 min after injection, at
30-s intervals. The mean heart rate for each injection was recorded.
Statistical analysis All analyses were undertaken with IBM SPSS Statistics (SPSS 26.0; SPSS
Inc., Chicago, IL). The anesthetic success rates were analyzed using the chi-square test. Age
differences were analyzed using One Way ANOVA, gender differences were analyzed using the
Fischer Exact test while heart rate changes were analysed with Kruskal Wallis test, being
non-normally distributed. Statistically significant differences were set at the P < 0.05
level
