Role of Vitamin E in Reducing Dry Socket

NCT05984173 | Completed Phase 4 DMC

• 1 other identifier: 7132023asu
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Socket

Keywords

dry socket

Outcome Measures

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

  one week

Study Arms (2)

study group

EXPERIMENTAL

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

Drug: Vitamin E application

control

NO INTERVENTION

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

Interventions

Vitamin E application DRUG

patients received vitamin E inside the socket after extraction

Also known as: tocopherol

study group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: only biological female because estrogen is limiting factor
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams University

Cairo, 11757, Egypt

Location

Related Publications (1)

• 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.

  PMID: 12190139 RESULT

MeSH Terms

Conditions

Dry Socket

Interventions

Tocopherols

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• mohamed diaa

  Ain shams

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial two groups

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: August 9, 2023
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 10, 2022
• Last Updated: August 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)