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CompletedNCT05984173Updated Aug 9, 2023

Role of Vitamin E in Reducing Dry Socket

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

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2022, registered Jul 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
Female
01

Study 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).

Read the 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.
02

Conditions studied

  • Dry Socket

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Keywords

  • dry socket
03

In context

Dry Socket

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Patients with any medical condition that may influence the outcome (uncontrolled diabetes, Hyperparathyroidism, Hyperthyroidism, Cushing's disease, Paget's disease, ).
  • 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, , 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.
Terms in these criteria, in plain language(3)

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.

Informed consent

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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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

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05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    study group

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

    Drug: Vitamin E application

  • No intervention
    control

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

Interventions

  • patients received vitamin E inside the socket after extraction

    Also known as: tocopherol

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Ain shams University
    Cairo, 11757, Egypt
08

References and documents

Publications

  • 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. PubMed 12190139 ↗

Individual participant data

Plan to share: No — Not planning to share

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05984173
Responsible party
Sponsor
First posted
Aug 9, 2023
Start date
Jan 1, 2022
Primary completion
Dec 1, 2022
Completion
Dec 10, 2022
Last update
Aug 9, 2023

Study contacts

mohamed diaa
study director · Ain shams

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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

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