Ain shams University
Cairo, 11757, Egypt
NCT Number: NCT05984173
90 female patients seeking extraction of a single tooth in the lower posterior region were divided randomly into 45 patients received vitamin E inside the socket after extraction (study group) and 45 patients didn't receive vitamin E after extraction (control group).
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Notify Me30 year–50 year
Female
Interventional
Phase 4
Cairo, 11757, Egypt
I. Patient Selection and Grouping:
This study was conducted on a total number of 90 female patients seeking extraction of a single tooth in the lower posterior region, selected from those attending the outpatient clinic of the oral and maxillofacial surgery department in the faculty of dentistry, Ain Shams University and Misr University for Science & Technology, Egypt as divided randomly into 45 patients received vitamin E inside the socket after extraction (study group) and 45 patients didn't receive vitamin E after extraction (control group).
II. Sample Size Calculation:
In the prior assessment of the article by Haraji et al. (Effects of Intra-alveolar Placement of 0.2% Chlorhexidine Bioadhesive Gel on Dry Socket Incidence and Postsurgical Pain: A Double-Blind Split-Mouth Randomized Controlled Clinical Trial) and setting alpha at 0.05 and Beta at 0.8 the data showed that the minimum number of patients to be included in each group was 18.
III. Blinding\\Masking:
Blinding of biostatistician was achieved while blinding of participants and operator wasn't possible as the operator is the outcome assessor.
IV. Research Ethics Approval:
The research was reviewed by the Research Ethics Committee (REC) of the Faculty of Dentistry, Ain Shams University.
V. Preoperative Assessment:
Each female has been evaluated for the following:
A. Medical History:
Full medical history was taken to exclude any patient according to the exclusion criteria.
B. Dental History:
Full dental history was taken including the history of previous incidences of dry socket.
C. Chief Complaint All patients were asked about the current dental chief complaint to exclude any patient who needed dental treatment other than extraction.
A. Extra-Oral Examination:
All patients were examined by the operator including facial appearance and facial bone.
B. Intra-Oral Examination:
This examination included:
Intra-oral Photographs were taken before establishing the surgical procedure. Figure (1)
A. Anesthetic Protocol:
The extraction procedures were done under local anesthesia using 4% articaine solution with adrenaline 1:100,000, as 1.2 ml for Inferior Alveolar Nerve block (IANB), 0.3 ml for lingual nerve block and 0.3 ml for long buccal nerve block on the side of the extraction.
B. Preparation of Gel Foam and Vitamin E:
A piece of gel foam was cut into 1 X1 cm2.
C. Extraction Procedure:
D. Packing of the Gel Foam:
The prepared gel foam was packed inside the socket to be covering the walls of the socket and not be oversized.
E. Suture with Figure 8:
A horizontal Figure 8 suture was applied for stabilization. Figure (3)
F. Post-Operative Instructions:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients received vitamin E inside the socket after extraction
Other names: tocopherol
Time frame: one week
Evaluation of patient satisfaction and pain was done and recorded according to VAS which is a scale from 1-10. patient mention degree of pain on this scale
Ain Shams University
Other
the Role of Vitamin E in Reducing Incidence of Dry Socket in Female Patients. A Randomized Clinical Trial
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