Alveolar OsteitisPhase 2NCT06823544
A Comparative Single Blind Clinical Study on the Effect of Alvogyl, Eugenol, and Nigella Sativa (Black Seed Oil) for Alveolar Osteitis.
A Phase 2 study testing Alvogyl, Eugenol and Nigella Sativa Oil in people with Alveolar Osteitis, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction. Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- Alvogyl, Eugenol and Nigella Sativa Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2025to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over the age of 16, from both genders, who had their teeth extracted and were clinically diagnosed with dry socket.
- Absence of systematic disease.
Who cannot join
- SMOKER
- ALCOHOLIC
- Patients under the age of 16 years and over the age of 70 years
- Patient with various bone diseases including osteoporosis.
- Patients who had a history of taking oral or intravenous bisphosphonates.
- Patients with a history of radiotherapy to the head and neck and jawbones.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS TAXILA CANTT
Taxila Cantt, Punjab Province, 47070
About this study
Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction.
Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Management can be by irrigation, surgical intervention and placement of medicated dressing such as topical anti-bacterial, topical anesthetics and obtundants or combination of these three.this study aims to find the best and effective treatment for dry socket comparing Alveogyl, Eugenol and Black seed oil at this institution.
Read the detailed description
Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction. Dry socket lesion occur in approximately 1% to 5% of all extraction and up to 38% of mandibular third molar extractions. The etiology of dry socket is not yet fully understood, however the disintegration of the blood clot at the site of the tooth extraction fails to develop i.e. fibrinolysis is widely accepted as the primary mechanism or it dislodges before wound has healed. Various factors have been associated with an increase of dry socket, although some of them remain controversial and many include difficult or traumatic extractions, oral hygiene, smoking, Gender (female), extraction site, previous dry socket history, while incidence can be reduced with the chlorhexidine rinse and gel of alveolar osteitis.
Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Management can be by irrigation, surgical intervention and placement of medicated dressing such as topical anti-bacterial, topical anesthetics and obtundants or combination of these three. Out of these Alveogyl is the still the material of choice in terms of pain relief, wound healing and low incidence of dry socket as compared to honey, zinc oxide eugenol and cutanplast , however in some recent studies a mixture of Nigella sativa powder and oil showed that it is more efficacious dressing material for the management of dry socket compared to alvogyl, it provided immediate and complete pain relief and fewer number of repeated visits needed while in some neocane was the most suitable dressing material for the management of dry socket by virtue of shorter time required for the complete pain relief, fewer visits required and faster clinical healing. Based on the previous data, we decided to conduct a study to evaluate the effectiveness of nigella sativa (black seed oil) for the treatment of dry socket compared to alveogyl and eugenol both. To the best of our knowledge, this is the first comparative study of nigella sativa oil for the treatment of dry socket at Oral and maxillofacial surgery department, HITEC dental college, Taxila and is aimed to find the best and effective treatment for dry socket comparing Alveogyl, Eugenol and Black seed oil at this institution.
- Conditions
- Alveolar Osteitis
- Being tested
- Alvogyl, Eugenol, Nigella Sativa Oil
- Keywords
- Alveolar Osteitis, Alvogyl, Black seed oil, Eugenol, Extraction 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.
AlvogylDrug
this is standard treatment drug
EugenolDrug
this not standard drug for the treatment of Alveolar Osteitis but an antiseptic agent
Nigella Sativa OilDrug
it not standard medicine for Alveolar Osteitis. it is a herbal medicine
| Study group | Role | What they receive |
|---|---|---|
| Alvogyl | Experimental | this group will be assigned Alvogyl as treatment drug Receives: Drug: Alvogyl |
| Eugenol | Experimental | this group will be assigned Eugenol as treatment drug Receives: Drug: Eugenol |
| Black Seed Oil | Experimental | this group will be assigned Nigella Sativa as treatment drug Receives: Drug: Nigella Sativa Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
pain will assessed using Visual Analogue scale on day 2, 6, 10 and 14th after the start of treatment. Visual Analogue Score measurement will be scale based from 1 to 10 score. Where 1-3 is mild, 3-7 is moderate and 7-10 will be scored as severe pain.
Measured: 14 days
Periodontal Probe
alveolar osteitis affected extraction socket will be observed for the resolution of inflammation and healing will be assessed on day 2, 6, 10 and 14 by clinical examination with periodontal Probe. Periodontal depth will be measured in mm, by using the periodontal probe where the depth of 1 to 3 mm is considered well healed socket, 4-6 mm indicates moderately inflamed, 7 mm and above is considered severely inflammed .
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar OsteitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Bilal, HITEC-Institute of Medical Sciences
- Investigators
- MAIMOONA Siddiq Dr, BDS-FCPS, Study director, Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMSMuhammad Bilal Dr, BDS, Principal investigator, Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823544
- Sponsor's protocol ID
- Bilalkhan321@gmail.com
- Status last verified
- Feb 2025
- First submitted
- 19 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: its not required for trial registry. if at any time during trial registration it is asked , i will provide the data
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Single Blind Clinical Study on the Effect of Alvogyl, Eugenol, and Nigella Sativa (Black Seed Oil) for Alveolar Osteitis.
- ClinicalTrials.gov ID
- NCT06823544
- Acronym / sponsor ID
- Bilalkhan321@gmail.com
- Conditions
- Alveolar Osteitis
- Keywords
- Alveolar Osteitis, Alvogyl, Black seed oil, Eugenol, Extraction socket
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 12 Feb 2025 (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.
Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction.
Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Management can be by irrigation, surgical intervention and placement of medicated dressing such as topical anti-bacterial, topical anesthetics and obtundants or combination of these three.this study aims to find the best and effective treatment for dry socket comparing Alveogyl, Eugenol and Black seed oil at this institution.
Detailed description
Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction. Dry socket lesion occur in approximately 1% to 5% of all extraction and up to 38% of mandibular third molar extractions. The etiology of dry socket is not yet fully understood, however the disintegration of the blood clot at the site of the tooth extraction fails to develop i.e. fibrinolysis is widely accepted as the primary mechanism or it dislodges before wound has healed. Various factors have been associated with an increase of dry socket, although some of them remain controversial and many include difficult or traumatic extractions, oral hygiene, smoking, Gender (female), extraction site, previous dry socket history, while incidence can be reduced with the chlorhexidine rinse and gel of alveolar osteitis.
Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Management can be by irrigation, surgical intervention and placement of medicated dressing such as topical anti-bacterial, topical anesthetics and obtundants or combination of these three. Out of these Alveogyl is the still the material of choice in terms of pain relief, wound healing and low incidence of dry socket as compared to honey, zinc oxide eugenol and cutanplast , however in some recent studies a mixture of Nigella sativa powder and oil showed that it is more efficacious dressing material for the management of dry socket compared to alvogyl, it provided immediate and complete pain relief and fewer number of repeated visits needed while in some neocane was the most suitable dressing material for the management of dry socket by virtue of shorter time required for the complete pain relief, fewer visits required and faster clinical healing. Based on the previous data, we decided to conduct a study to evaluate the effectiveness of nigella sativa (black seed oil) for the treatment of dry socket compared to alveogyl and eugenol both. To the best of our knowledge, this is the first comparative study of nigella sativa oil for the treatment of dry socket at Oral and maxillofacial surgery department, HITEC dental college, Taxila and is aimed to find the best and effective treatment for dry socket comparing Alveogyl, Eugenol and Black seed oil at this institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alvogyl | Experimental | Drug: Alvogylthis group will be assigned Alvogyl as treatment drug |
| Eugenol | Experimental | Drug: Eugenolthis group will be assigned Eugenol as treatment drug |
| Black Seed Oil | Experimental | Drug: Nigella Sativa Oilthis group will be assigned Nigella Sativa as treatment drug |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 16, from both genders, who had their teeth extracted and were clinically diagnosed with dry socket.
- Absence of systematic disease.
Key exclusion criteria (6 listed)
- SMOKER
- ALCOHOLIC
- Patients under the age of 16 years and over the age of 70 years
- Patient with various bone diseases including osteoporosis.
- Patients who had a history of taking oral or intravenous bisphosphonates.
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 |
|---|---|---|
| Alvogylthis is standard treatment drug | Drug | Alvogyl |
| Eugenolthis not standard drug for the treatment of Alveolar Osteitis but an antiseptic agent | Drug | Eugenol |
| Nigella Sativa Oilit not standard medicine for Alveolar Osteitis. it is a herbal medicine | Drug | Black Seed Oil |
Primary outcome
Visual Analogue Scale
Time frame: 14 days
pain will assessed using Visual Analogue scale on day 2, 6, 10 and 14th after the start of treatment. Visual Analogue Score measurement will be scale based from 1 to 10 score. Where 1-3 is mild, 3-7 is moderate and 7-10 will be scored as severe pain.
Periodontal Probe
Time frame: 14 days
alveolar osteitis affected extraction socket will be observed for the resolution of inflammation and healing will be assessed on day 2, 6, 10 and 14 by clinical examination with periodontal Probe. Periodontal depth will be measured in mm, by using the periodontal probe where the depth of 1 to 3 mm is considered well healed socket, 4-6 mm indicates moderately inflamed, 7 mm and above is considered severely inflammed .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No. its not required for trial registry. if at any time during trial registration it is asked , i will provide the data
Related trials for Alveolar Osteitis
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.
MAIMOONA Siddiq Dr, BDS-FCPS study director
Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS
Muhammad Bilal Dr, BDS principal investigator
Department of Oral & Maxillofacial Surgery-Dental College HITEC-IMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alvogyl, Eugenol and Nigella Sativa Oil in people with Alveolar Osteitis, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Feb 2025. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MUHAMMAD BILAL (+92519315698, Bilalkhan321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.