Apostolina Theocharidou1, Aristidis Arhakis2, Nikolaos Kotsanos2, Konstantinos Arapostathis2. 1. School of Dentistry, Department of Pediatric Dentistry, Aristotle University of Thessaloniki, GR-54124, Thessaloniki, Greece. apostolinatheocharidou@gmail.com. 2. School of Dentistry, Department of Pediatric Dentistry, Aristotle University of Thessaloniki, GR-54124, Thessaloniki, Greece.
Abstract
OBJECTIVES: To compare the efficacy, acceptance and preference of conventional infiltration technique with a needleless jet anaesthetic device (Comfort-In). MATERIALS AND METHODS: Non-fearful healthy adult volunteers, aged 19-40 years, were recruited in the Dental School of Aristotle University of Thessaloniki, Greece. Intact maxillary premolars were selected for local anaesthesia. Both techniques were applied sequentially with 35 min time gap on either buccal side on the same day by the same operator. The quadrant and the order of administration were randomly assigned using an online randomization generator. Immediately after administration, at 1, 3, 5, 10, 15, 20, 25 and 30 min, pulp vitality and soft tissue pain reaction tests were performed. Each participant was asked 6 questions in order to assess acceptance. At the end of the session, at 24 h and 7 days, all participants were asked to report any adverse events and their preference. RESULTS: In 63 volunteers who were successfully followed, 63 teeth receivedconventional local infiltration and 63 the Comfort-In. Both techniques presented with similar anaesthetic efficacy at 1, 3, 5, 10 and 15 min, whereas the conventional technique was more efficacious at 20 min (p < 0.005). Both presented similar acceptance apart from higher pain/discomfort during administration of Comfort-In (p = 0.002). Significantly higher preference was reported for the conventional technique immediately after the session, at 24 h and at 7 days (p < 0.0005); 19 (30.2%) reported the presence of ecchymosis or lacerations at the Comfort-In site as opposed to 5 (7.9%) with the conventional method (p < 0.0001). CONCLUSION: Both techniques showed similar effectiveness. Conventional infiltration was preferred to needleless anaesthesia by non-fearful adult volunteers and was associated with less adverse events. CLINICAL RELEVANCE: This study enhances the advantages of conventional local anaesthesia. TRIAL REGISTRATION: ISRCTN17400733.
RCT Entities:
OBJECTIVES: To compare the efficacy, acceptance and preference of conventional infiltration technique with a needleless jet anaesthetic device (Comfort-In). MATERIALS AND METHODS: Non-fearful healthy adult volunteers, aged 19-40 years, were recruited in the Dental School of Aristotle University of Thessaloniki, Greece. Intact maxillary premolars were selected for local anaesthesia. Both techniques were applied sequentially with 35 min time gap on either buccal side on the same day by the same operator. The quadrant and the order of administration were randomly assigned using an online randomization generator. Immediately after administration, at 1, 3, 5, 10, 15, 20, 25 and 30 min, pulp vitality and soft tissue pain reaction tests were performed. Each participant was asked 6 questions in order to assess acceptance. At the end of the session, at 24 h and 7 days, all participants were asked to report any adverse events and their preference. RESULTS: In 63 volunteers who were successfully followed, 63 teeth received conventional local infiltration and 63 the Comfort-In. Both techniques presented with similar anaesthetic efficacy at 1, 3, 5, 10 and 15 min, whereas the conventional technique was more efficacious at 20 min (p < 0.005). Both presented similar acceptance apart from higher pain/discomfort during administration of Comfort-In (p = 0.002). Significantly higher preference was reported for the conventional technique immediately after the session, at 24 h and at 7 days (p < 0.0005); 19 (30.2%) reported the presence of ecchymosis or lacerations at the Comfort-In site as opposed to 5 (7.9%) with the conventional method (p < 0.0001). CONCLUSION: Both techniques showed similar effectiveness. Conventional infiltration was preferred to needleless anaesthesia by non-fearful adult volunteers and was associated with less adverse events. CLINICAL RELEVANCE: This study enhances the advantages of conventional local anaesthesia. TRIAL REGISTRATION: ISRCTN17400733.