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Dry SocketPhase 4NCT05984173

Role of Vitamin E in Reducing Dry Socket

A Phase 4 study testing Vitamin E application in people with Dry Socket, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 30 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Dry Socket
What is being tested?
Vitamin E application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Jan 2022to 10 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • Lactating mothers.
  • Smoking patients.
  • Patients currently on radiotherapy and or chemotherapy treatment.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain shams University

    Cairo, 11757

Other trials in Egypt

About this study

Official title: the Role of Vitamin E in Reducing Incidence of Dry Socket in Female Patients. A Randomized Clinical Trial

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
  1. 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.

  1. Preoperative Assessment:
  2. Patient Evaluation: Each female has been evaluated for the following:
  3. Medical History: Full medical history was taken to exclude any patient according to the exclusion criteria.
  4. Dental History: Full dental history was taken including the history of previous incidences of dry socket.
  5. Chief Complaint All patients were asked about the current dental chief complaint to exclude any patient who needed dental treatment other than extraction.
  6. Clinical Examination:
  7. Extra-Oral Examination: All patients were examined by the operator including facial appearance and facial bone.
  8. 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.
  1. 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.
  2. Photography: Intra-oral Photographs were taken before establishing the surgical procedure. Figure (1)
  3. Surgical Preparation:
  4. 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.

  1. Preparation of Gel Foam and Vitamin E:

A piece of gel foam was cut into 1 X1 cm2.

  1. 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)
  1. 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.

  1. Suture with Figure 8:

A horizontal Figure 8 suture was applied for stabilization. Figure (3)

  1. 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.
Conditions
Dry Socket
Being tested
Vitamin E application
Keywords
dry socket
Medical subject headings
Dry Socket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin E applicationDrug

    Also called tocopherol

    patients received vitamin E inside the socket after extraction

Study groups in NCT05984173
Study groupRoleWhat they receive
study groupExperimentalpatients received vitamin E inside the socket after extraction (study group)
Receives: Drug: Vitamin E application
controlNo interventionpatients didn't receive vitamin E after extraction (control group).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start1 Jan 2022
  3. Primary completion1 Dec 2022
  4. Study completion10 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial two groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05984173
Sponsor's protocol ID
7132023asu
Status last verified
Jan 2023
First submitted
22 Jul 2023
Last updated
9 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not planning to share

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin E application in people with Dry Socket, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease of incidence of dry socket and pain (time frame: one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05984173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.

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