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.
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.
Show all 9Show fewer
- Lactating mothers.
- Smoking patients.
- Patients currently on radiotherapy and or chemotherapy treatment.
Trial locations and contacts
1 site in 1 country.
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
- 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.
- Preoperative Assessment:
- Patient Evaluation: Each female has been evaluated for the following:
- Medical History: Full medical history was taken to exclude any patient according to the exclusion criteria.
- Dental History: Full dental history was taken including the history of previous incidences of dry socket.
- 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:
- Extra-Oral Examination: All patients were examined by the operator including facial appearance and facial bone.
- 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:
- 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.
- Preparation of Gel Foam and Vitamin E:
A piece of gel foam was cut into 1 X1 cm2.
- 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)
- 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.
- Suture with Figure 8:
A horizontal Figure 8 suture was applied for stabilization. Figure (3)
- 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 group | Role | What they receive |
|---|---|---|
| study group | Experimental | patients received vitamin E inside the socket after extraction (study group) Receives: Drug: Vitamin E application |
| control | No intervention | patients 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.
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.
- First posted9 Aug 2023
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry SocketStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohamed diaa, Study director, Ain shams
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Role of Vitamin E in Reducing Incidence of Dry Socket in Female Patients. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05984173
- Acronym / sponsor ID
- 7132023asu
- Conditions
- Dry Socket
- Keywords
- dry socket
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Preoperative Assessment:
- Patient Evaluation: Each female has been evaluated for the following:
- Medical History: Full medical history was taken to exclude any patient according to the exclusion criteria.
- Dental History: Full dental history was taken including the history of previous incidences of dry socket.
- 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:
- Extra-Oral Examination: All patients were examined by the operator including facial appearance and facial bone.
- 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:
- 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.
- Preparation of Gel Foam and Vitamin E:
A piece of gel foam was cut into 1 X1 cm2.
- 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)
- 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.
- Suture with Figure 8:
A horizontal Figure 8 suture was applied for stabilization. Figure (3)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial two groups
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Vitamin E applicationpatients received vitamin E inside the socket after extraction (study group) |
| control | No intervention | –patients didn't receive vitamin E after extraction (control group). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E applicationAlso: tocopherolpatients received vitamin E inside the socket after extraction | Drug | study group |
Primary outcome
Decrease of incidence of dry socket and pain
Time frame: one week
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Results publication: PubMed 12190139Blum 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.
- Individual participant dataSharing planned: No. Not planning to share
Related trials for Dry Socket
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Not yet recruiting
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
Alveolar Osteitis
Active, not recruiting
Alvogyl Versus Platelet-Rich Fibrin for Healing of Alveolar Osteitis
Alveolar Osteitis
Active, not recruiting
Chlorhexidine Versus Normal Saline Socket Irrigation for Prevention of Dry Socket After Lower Wisdom Tooth Extraction
Alveolar Osteitis, Impacted Lower Third Molar
Not yet recruiting
Effectiveness of Telephonic and Digital Postoperative Follow-up Communication Strategies on Patient Compliance, Clinical Recovery, and Quality of Life After Dental Extraction
Tooth Extraction, Postoperative Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed diaa study director
Ain shams
1 site in 1 country: see every site and its status.
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.