Clinical trial NCT05984173: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Socket
Keywords: dry socket
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial two groups
Primary purpose: TREATMENT

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:

1. 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.
2. 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.
3. 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.
4. Photography:

   Intra-oral Photographs were taken before establishing the surgical procedure. Figure (1)
5. 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.

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.

Primary outcomes:
measure: Decrease of incidence of dry socket and pain
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams University
Study officials:
affiliation: Ain shams
name: mohamed diaa
role: STUDY_DIRECTOR
References:
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.