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Role of Vitamin E in Reducing Dry Socket

Primary Purpose

Dry Socket

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin E application
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Socket focused on measuring dry socket

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female patients 30-50 years of age. Patients with single tooth in the lower posterior region need simple extraction. Compliance with all requirements in the study and signing the informed consent. Exclusion Criteria: Patients with any medical condition that may influence the outcome (uncontrolled diabetes, Hyperparathyroidism, Hyperthyroidism, Cushing's disease, Paget's disease, Glucocorticoids). Vulnerable groups (children, pregnant women, elderly people, malnourished people, prisoners, migrants, and refugees). Patients with systemic disease affecting bone healing (osteoporosis, Rickets, and osteomalacia). Chronic Patients on medications known to affect the periodontal status (calcium antagonists, anticonvulsive, immunosuppressive, anti-inflammatory medications). Patients with a history of bisphosphonate use. Pathologic lesions in the site of extraction. Lactating mothers. Smoking patients. Patients currently on radiotherapy and or chemotherapy treatment.

Sites / Locations

  • Ain shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

study group

control

Arm Description

patients received vitamin E inside the socket after extraction (study group)

patients didn't receive vitamin E after extraction (control group).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 22, 2023
Last Updated
August 8, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05984173
Brief Title
Role of Vitamin E in Reducing Dry Socket
Official Title
the Role of Vitamin E in Reducing Incidence of Dry Socket in Female Patients. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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: General examination of oral health, checking the teeth adjacent to the extracted tooth and oral hard and soft tissues. Examination of extracted tooth including tenderness and mobility tests. Radiographic Assessment Radiographic assessment was done using a periapical radiograph to examine the surrounding bone, exclude any pathological lesion, and detect the location of the inferior alveolar canal, especially during extraction of lower third molars. Photography: Intra-oral Photographs were taken before establishing the surgical procedure. Figure (1) Surgical Preparation: 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: All extractions were performed by the same surgeon using standard English-Style Vertical Hinge forceps in a standardized buccolingual technique for socket expansion. The extraction procedures were done simply using forceps or elevators without raising mucoperiosteal flaps or anything that make the procedure surgical. Figure (2) 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: Keep biting on the gauze for 1 hour. Avoid eating or drinking hot stuff on the first post-extraction day. Soft and cold food can be consumed after 2 hours on the other side. Avoid rinsing for the next 24 hours after extraction. Rinsing the mouth with warm saline 3 times daily on the 2nd day and continued for 5 days. Avoid smoking. Rest and avoid strenuous activities for the remainder of the day. Patients were given a prescription for Diclofenac Potassium to be used twice daily for three days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Socket
Keywords
dry socket

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial two groups
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
patients received vitamin E inside the socket after extraction (study group)
Arm Title
control
Arm Type
No Intervention
Arm Description
patients didn't receive vitamin E after extraction (control group).
Intervention Type
Drug
Intervention Name(s)
Vitamin E application
Other Intervention Name(s)
tocopherol
Intervention Description
patients received vitamin E inside the socket after extraction
Primary Outcome Measure Information:
Title
Decrease of incidence of dry socket and pain
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only biological female because estrogen is limiting factor
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female patients 30-50 years of age. Patients with single tooth in the lower posterior region need simple extraction. Compliance with all requirements in the study and signing the informed consent. Exclusion Criteria: Patients with any medical condition that may influence the outcome (uncontrolled diabetes, Hyperparathyroidism, Hyperthyroidism, Cushing's disease, Paget's disease, Glucocorticoids). Vulnerable groups (children, pregnant women, elderly people, malnourished people, prisoners, migrants, and refugees). Patients with systemic disease affecting bone healing (osteoporosis, Rickets, and osteomalacia). Chronic Patients on medications known to affect the periodontal status (calcium antagonists, anticonvulsive, immunosuppressive, anti-inflammatory medications). Patients with a history of bisphosphonate use. Pathologic lesions in the site of extraction. Lactating mothers. Smoking patients. Patients currently on radiotherapy and or chemotherapy treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed diaa
Organizational Affiliation
Ain shams
Official's Role
Study Director
Facility Information:
Facility Name
Ain shams University
City
Cairo
ZIP/Postal Code
11757
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not planning to share
Citations:
PubMed Identifier
12190139
Citation
Blum IR. Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of standardization, aetiopathogenesis and management: a critical review. Int J Oral Maxillofac Surg. 2002 Jun;31(3):309-17. doi: 10.1054/ijom.2002.0263.
Results Reference
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Role of Vitamin E in Reducing Dry Socket

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