A Phase 4 interventional study of Vitamin E application in Dry Socket, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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).
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:
Patient Evaluation:
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.
Clinical Examination:
A. Extra-Oral Examination:
All patients were examined by the operator including facial appearance and facial bone.
B. Intra-Oral Examination:
This examination included:
Photography:
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:
46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 41 interventional studies indexed under Dry Socket.
Browse Dry Socket studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
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patients received vitamin E inside the socket after extraction (study group)
Drug: Vitamin E application
patients didn't receive vitamin E after extraction (control group).
patients received vitamin E inside the socket after extraction
Also known as: tocopherol
Decrease of incidence of dry socket and pain
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
Time frame: one week
Plan to share: No — Not planning to share
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tocopherols