Omer Waleed Majid1, Bashar Adil Al-Mashhadani2. 1. Assistant Professor, Department of Oral and Maxillofacial Surgery, University of Mosul College of Dentistry, Mosul, Iraq. Electronic address: omerw_majid@yahoo.co.uk. 2. Postgraduate Student, Master's Degree, Department of Oral and Maxillofacial Surgery, University of Mosul College of Dentistry, Mosul, Iraq.
Abstract
PURPOSE: The purpose of the present study was to compare the effect of oral bromelain (4 × 250 mg) versus oral diclofenac sodium (4 × 25 mg) on pain, swelling, trismus, and quality of life (QOL) after surgical removal of impacted lower third molars. PATIENTS AND METHODS: A randomized, double-blind, placebo-controlled study was planned. The sample included patients requiring extraction under local anesthesia of a single partial bony impacted mandibular third molar. The patients were randomly distributed into 1 of 3 groups: bromelain, diclofenac, and placebo. Treatment started 1 day before surgery and continued for 4 days. The predictor variable was the type of the drug given to the patients. The outcome variables were pain, swelling, and trismus, which were measured at 1, 3, and 7 days postoperatively. The other study variables included QOL measures to assess the patients' perception regarding the effect of surgery on their well-being and daily activities. A validated questionnaire was used to measure QOL. The data were analyzed using analysis of variance, multiple measures analysis of variance, or Pearson's χ(2) test, as appropriate. P < .05 was considered significant. RESULTS: A total of 45 subjects requiring surgical removal of a single impacted mandibular third molar under local anesthesia were included in the present study. The bromelain and diclofenac groups both showed a significant reduction in pain compared with the placebo group at all intervals (P < .05). Diclofenac also resulted in a significant reduction of swelling at 3 and 7 days, and bromelain resulted in an insignificant reduction. A nonsignificant reduction in trismus occurred in both treatment groups compared with the placebo group. Both treatment groups also showed a significant difference in the effect on QOL in most subscales and total scores (P < .05). The effect was comparable between the 2 treatment groups for all parameters and at all intervals. CONCLUSIONS: The results of our study have shown that oral bromelain is an effective therapy to improve the QOL after surgical removal of impacted lower third molars, with an effect on the postoperative sequelae comparable to that of preemptive diclofenac sodium.
RCT Entities:
PURPOSE: The purpose of the present study was to compare the effect of oral bromelain (4 × 250 mg) versus oral diclofenac sodium (4 × 25 mg) on pain, swelling, trismus, and quality of life (QOL) after surgical removal of impacted lower third molars. PATIENTS AND METHODS: A randomized, double-blind, placebo-controlled study was planned. The sample included patients requiring extraction under local anesthesia of a single partial bony impacted mandibular third molar. The patients were randomly distributed into 1 of 3 groups: bromelain, diclofenac, and placebo. Treatment started 1 day before surgery and continued for 4 days. The predictor variable was the type of the drug given to the patients. The outcome variables were pain, swelling, and trismus, which were measured at 1, 3, and 7 days postoperatively. The other study variables included QOL measures to assess the patients' perception regarding the effect of surgery on their well-being and daily activities. A validated questionnaire was used to measure QOL. The data were analyzed using analysis of variance, multiple measures analysis of variance, or Pearson's χ(2) test, as appropriate. P < .05 was considered significant. RESULTS: A total of 45 subjects requiring surgical removal of a single impacted mandibular third molar under local anesthesia were included in the present study. The bromelain and diclofenac groups both showed a significant reduction in pain compared with the placebo group at all intervals (P < .05). Diclofenac also resulted in a significant reduction of swelling at 3 and 7 days, and bromelain resulted in an insignificant reduction. A nonsignificant reduction in trismus occurred in both treatment groups compared with the placebo group. Both treatment groups also showed a significant difference in the effect on QOL in most subscales and total scores (P < .05). The effect was comparable between the 2 treatment groups for all parameters and at all intervals. CONCLUSIONS: The results of our study have shown that oral bromelain is an effective therapy to improve the QOL after surgical removal of impacted lower third molars, with an effect on the postoperative sequelae comparable to that of preemptive diclofenac sodium.
Authors: Satish Sagar; Ashok Kumar Rathinavel; William E Lutz; Lucas R Struble; Surender Khurana; Andy T Schnaubelt; Nitish Kumar Mishra; Chittibabu Guda; Nicholas Y Palermo; Mara J Broadhurst; Tobias Hoffmann; Kenneth W Bayles; St Patrick M Reid; Gloria E O Borgstahl; Prakash Radhakrishnan Journal: Clin Transl Med Date: 2021-02
Authors: Satish Sagar; Ashok Kumar Rathinavel; William E Lutz; Lucas R Struble; Surender Khurana; Andy T Schnaubelt; Nitish Kumar Mishra; Chittibabu Guda; Mara J Broadhurst; St Patrick M Reid; Kenneth W Bayles; Gloria E O Borgstahl; Prakash Radhakrishnan Journal: bioRxiv Date: 2020-09-16