Dry SocketPhase 1NCT06456060
Efficacy of Pure Honey Dressing in Contrast to Alvogyl in the Resolution of Dry Socket
A Phase 1 study testing Alvogyl and Honey in people with Dry Socket, run by Watim Medical & Dental College at 1 site in Pakistan.
Trial summary
Dry socket, or Alveolar Osteitis, is the most common complication that can follow a tooth extraction. Over the years, various approaches have been employed to expedite the healing process and alleviate the associated symptoms. Among these, Alvogyl has been the most commonly used dry socket dressing all over the globe. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dry Socket
- What is being tested?
- Alvogyl and Honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2024to 30 Jan 2025
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age of both genders.
- Patients who underwent extraction of teeth and were clinically diagnosed with dry socket at the OMFS department of NID, Multan.
- Patients which give informed consent.
Who cannot join
- Patients below the age of 18 and above the age of 70.
- Patients with various bone diseases, including osteoporosis \& a history of taking oral or intravenous bisphosphonates
- Patients with a history of radiotherapy on the head, neck, and jawbones were excluded from this study,
- Patients with systemic diseases such as diabetes mellitus, hepatic dysfunctions, blood dyscrasias, and bleeding disorders
- Patients with allergy to Ibuprofen \& honey
- Patients having symptoms similar to dry socket due to retained root pieces, oroantral communication, or any bony or soft tissue pathology by the help of a radiograph
- Patients who did not give informed consent.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Nishtar Institute of Dentistry
Multan Khurd, Punjab Province
M Raif ilyas, BDS, FCPS 1, +923319268801, raifilyas@gmail.com
About this study
Official title: Exploring the Efficacy of Pure Honey Dressing in Contrast to Alvogyl in the Resolution of Dry Socket: A Comparative Analysis
Dry socket, or Alveolar Osteitis, is the most common complication that can follow a tooth extraction. Over the years, various approaches have been employed to expedite the healing process and alleviate the associated symptoms. Among these, Alvogyl has been the most commonly used dry socket dressing all over the globe. However due to Alvogyl's potential side effect of causing a foreign body reaction \& ultimately necrosis of the alveolar bone if left in the socket along with its high cost, scientists have sought to develop new techniques. Among them, Honey dressing has heralded promising properties in facilitating the resolution of dry socket, thus opening the window of a side-effect free natural viable alternative to Alvogyl. In this research, we aim to compare the efficacy of pure Honey as a dry socket dressing in comparison to Alvogyl.
Read the detailed description
This will be an interventional study, carried out using a quasi-experimental design.
After making the diagnosis of Alveolar osteitis by means of clinical examination and radiograph, Demographic data along with other associated information such as their medical condition, tooth indicated for extraction, pre-operative pain, and halitosis will be documented.
With 20 patients in each, Patients will be divided into the following two groups:
- Study group
- Control group
In the study group, after flushing the socket with normal saline, 2 ml of Honey soaked in a sterile gauze will be applied to cover the socket, whereas in the control group, a gauze with Alveogyl will be used to cover the socket instead of Honey.
Patients will be allowed to continue their oral analgesic medication, namely Ibuprofen 200 mg, 400 mg, or 600 mg twice daily, depending upon the severity of initial pain upon diagnosis. Pain relief will be recorded and compared between the two groups on a visual analog pain scale at every appointment.
The intra-alveolar packing will be continued \& will be kept being changed at regular intervals until the postoperative pain symptoms subside. Patients will be reviewed at 5 min post-medication, 30 min post-medication, 60 min post-medication, 2nd day post-medication, 4th day post-medication and 7th day post-medication. The patients will be requested to note daily pain records on a (0-10) visual analog scale, with 0 representing no pain and 10 representing the worst pain.
For safety purposes, any harmful effects of the medications will also be recorded. Patients will be instructed to call the investigator immediately about any problem \& in such circumstances, treatment will be immediately terminated and discontinued. The patient will be requested to visit the investigator at the earliest possible time. If no side effects are noted, the treatment option will be repeated a maximum of four times over two weeks to assess the complete effect of the medication in case complete relief was not achieved the first time. The total time required for complete healing and the number of repeated sessions for each medication until complete relief from all symptoms will be recorded in Performa, attached as Annexure.
The success rate of the procedure will be categorized into excellent, good, fair, and poor, according to pain relief, the need to use oral analgesics and the number of repeated sessions for each medication.
Excellent: complete relief of pain without the use of analgesics; pain score = 0 (no pain) Good: complete relief of pain with modest use of analgesics (200 mg ibuprofen); pain score: 1-3 (mild) Fair: complete relief of pain with moderate use of analgesics (400 mg ibuprofen); pain score: 4-6 (moderate pain) Poor: continued pain despite high dose of analgesics (600 mg ibuprofen); pain score 7-10 (severe pain)
- Conditions
- Dry Socket
- Being tested
- Alvogyl, Honey
- 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
Alvogyl soaked in a sterile gauze will be applied to cover the socket.
HoneyDrug
Honey soaked in a sterile gauze will be applied to cover the socket.
| Study group | Role | What they receive |
|---|---|---|
| Control (Alvogyl) Group | Active comparator | In Control Group, after flushing the socket with normal saline a gauze soaked with Alvogyl will be used to cover the socket.. Receives: Drug: Alvogyl |
| Study (Honey) Group | Experimental | In the Study (Honey) Group, after flushing the socket with normal saline, 2 ml of Honey soaked in a sterile gauze will be applied to cover the socket. Receives: Drug: Honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
The patients will be requested to note daily pain records on a (0-10) visual analog scale, with 0 representing no pain and 10 representing the worst pain..
Measured: Patients will be reviewed at 5 min post-medication, 30 min post-medication, 60 min post-medication, 2nd day post-medication, 4th day post-medication and 7th day post-medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jun 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided into the following two groups: 1. Study group 2. Control group In the study group, after flushing the socket with normal saline, 2 ml of Honey soaked in a sterile gauze will be applied to cover the socket, whereas in the control group, a gauze with Alveogyl will be used to cover the socket instead of Honey.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ilyas, Watim Medical & Dental College
- Investigators
- Muhammad Ilyas, MBBS, FCPS, Study director, Watim Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456060
- Sponsor's protocol ID
- 639/NID/24
- Status last verified
- Jul 2024
- First submitted
- 6 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keshini MP, Shetty SK, Sundar S, Chandan SN, Manjula S. Assessment of Healing Using Alvogyl and Platelet Rich Fibrin in Patients with Dry Socket - An Evaluative Study. Ann Maxillofac Surg. 2020 Jul-Dec;10(2):320-324. doi: 10.4103/ams.ams_259_19. Epub 2020 Dec 23.
PubMed 33708574Abu-Mostafa N, Al-Daghamin S, Al-Anazi A, Al-Jumaah N, Alnesafi A. The influence of intra-alveolar application of honey versus Chlorhexidine rinse on the incidence of Alveolar Osteitis following molar teeth extraction. A randomized clinical parallel trial. J Clin Exp Dent. 2019 Oct 1;11(10):e871-e876. doi: 10.4317/jced.55743. eCollection 2019 Oct.
PubMed 31636855Soni N, Singh V, Mohammad S, Singh RK, Pal US, Singh R, Aggrwal J, Pal M. Effects of honey in the management of alveolar osteitis: A study. Natl J Maxillofac Surg. 2016 Jul-Dec;7(2):136-147. doi: 10.4103/0975-5950.201354.
PubMed 28356684
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy of Pure Honey Dressing in Contrast to Alvogyl in the Resolution of Dry Socket: A Comparative Analysis
- ClinicalTrials.gov ID
- NCT06456060
- Acronym / sponsor ID
- 639/NID/24
- Conditions
- Dry Socket
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 13 Jun 2024 (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, or Alveolar Osteitis, is the most common complication that can follow a tooth extraction. Over the years, various approaches have been employed to expedite the healing process and alleviate the associated symptoms. Among these, Alvogyl has been the most commonly used dry socket dressing all over the globe. However due to Alvogyl's potential side effect of causing a foreign body reaction \& ultimately necrosis of the alveolar bone if left in the socket along with its high cost, scientists have sought to develop new techniques. Among them, Honey dressing has heralded promising properties in facilitating the resolution of dry socket, thus opening the window of a side-effect free natural viable alternative to Alvogyl. In this research, we aim to compare the efficacy of pure Honey as a dry socket dressing in comparison to Alvogyl.
Detailed description
This will be an interventional study, carried out using a quasi-experimental design.
After making the diagnosis of Alveolar osteitis by means of clinical examination and radiograph, Demographic data along with other associated information such as their medical condition, tooth indicated for extraction, pre-operative pain, and halitosis will be documented.
With 20 patients in each, Patients will be divided into the following two groups:
- Study group
- Control group
In the study group, after flushing the socket with normal saline, 2 ml of Honey soaked in a sterile gauze will be applied to cover the socket, whereas in the control group, a gauze with Alveogyl will be used to cover the socket instead of Honey.
Patients will be allowed to continue their oral analgesic medication, namely Ibuprofen 200 mg, 400 mg, or 600 mg twice daily, depending upon the severity of initial pain upon diagnosis. Pain relief will be recorded and compared between the two groups on a visual analog pain scale at every appointment.
The intra-alveolar packing will be continued \& will be kept being changed at regular intervals until the postoperative pain symptoms subside. Patients will be reviewed at 5 min post-medication, 30 min post-medication, 60 min post-medication, 2nd day post-medication, 4th day post-medication and 7th day post-medication. The patients will be requested to note daily pain records on a (0-10) visual analog scale, with 0 representing no pain and 10 representing the worst pain.
For safety purposes, any harmful effects of the medications will also be recorded. Patients will be instructed to call the investigator immediately about any problem \& in such circumstances, treatment will be immediately terminated and discontinued. The patient will be requested to visit the investigator at the earliest possible time. If no side effects are noted, the treatment option will be repeated a maximum of four times over two weeks to assess the complete effect of the medication in case complete relief was not achieved the first time. The total time required for complete healing and the number of repeated sessions for each medication until complete relief from all symptoms will be recorded in Performa, attached as Annexure.
The success rate of the procedure will be categorized into excellent, good, fair, and poor, according to pain relief, the need to use oral analgesics and the number of repeated sessions for each medication.
Excellent: complete relief of pain without the use of analgesics; pain score = 0 (no pain) Good: complete relief of pain with modest use of analgesics (200 mg ibuprofen); pain score: 1-3 (mild) Fair: complete relief of pain with moderate use of analgesics (400 mg ibuprofen); pain score: 4-6 (moderate pain) Poor: continued pain despite high dose of analgesics (600 mg ibuprofen); pain score 7-10 (severe pain)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be divided into the following two groups: 1. Study group 2. Control group In the study group, after flushing the socket with normal saline, 2 ml of Honey soaked in a sterile gauze will be applied to cover the socket, whereas in the control group, a gauze with Alveogyl will be used to cover the socket instead of Honey.
| Arm | Type | Receives |
|---|---|---|
| Control (Alvogyl) Group | Active comparator | Drug: AlvogylIn Control Group, after flushing the socket with normal saline a gauze soaked with Alvogyl will be used to cover the socket.. |
| Study (Honey) Group | Experimental | Drug: HoneyIn the Study (Honey) Group, after flushing the socket with normal saline, 2 ml of Honey soaked in a sterile gauze will be applied to cover the socket. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age of both genders.
- Patients who underwent extraction of teeth and were clinically diagnosed with dry socket at the OMFS department of NID, Multan.
- Patients which give informed consent.
Key exclusion criteria (7 listed)
- Patients below the age of 18 and above the age of 70.
- Patients with various bone diseases, including osteoporosis \& a history of taking oral or intravenous bisphosphonates
- Patients with a history of radiotherapy on the head, neck, and jawbones were excluded from this study,
- Patients with systemic diseases such as diabetes mellitus, hepatic dysfunctions, blood dyscrasias, and bleeding disorders
- Patients with allergy to Ibuprofen \& honey
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 |
|---|---|---|
| AlvogylAlvogyl soaked in a sterile gauze will be applied to cover the socket. | Drug | Control (Alvogyl) Group |
| HoneyHoney soaked in a sterile gauze will be applied to cover the socket. | Drug | Study (Honey) Group |
Primary outcome
Pain relief
Time frame: Patients will be reviewed at 5 min post-medication, 30 min post-medication, 60 min post-medication, 2nd day post-medication, 4th day post-medication and 7th day post-medication.
The patients will be requested to note daily pain records on a (0-10) visual analog scale, with 0 representing no pain and 10 representing the worst pain..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Results publication: PubMed 33708574Keshini MP, Shetty SK, Sundar S, Chandan SN, Manjula S. Assessment of Healing Using Alvogyl and Platelet Rich Fibrin in Patients with Dry Socket - An Evaluative Study. Ann Maxillofac Surg. 2020 Jul-Dec;10(2):320-324. doi: 10.4103/ams.ams_259_19. Epub 2020 Dec 23.
- Results publication: PubMed 31636855Abu-Mostafa N, Al-Daghamin S, Al-Anazi A, Al-Jumaah N, Alnesafi A. The influence of intra-alveolar application of honey versus Chlorhexidine rinse on the incidence of Alveolar Osteitis following molar teeth extraction. A randomized clinical parallel trial. J Clin Exp Dent. 2019 Oct 1;11(10):e871-e876. doi: 10.4317/jced.55743. eCollection 2019 Oct.
- Results publication: PubMed 28356684Soni N, Singh V, Mohammad S, Singh RK, Pal US, Singh R, Aggrwal J, Pal M. Effects of honey in the management of alveolar osteitis: A study. Natl J Maxillofac Surg. 2016 Jul-Dec;7(2):136-147. doi: 10.4103/0975-5950.201354.
- Individual participant dataSharing planned: No
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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.
Muhammad Ilyas, MBBS, FCPS study director
Watim Medical & Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alvogyl and Honey in people with Dry Socket, run by Watim Medical & Dental College 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Raif Ilyas, BDS, FCPS -1 (00923319268801, raifilyas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: Patients will be reviewed at 5 min post-medication, 30 min post-medication, 60 min post-medication, 2nd day post-medication, 4th day post-medication and 7th day post-medication.). 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 NCT06456060, which also lists 3 linked publications.
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 23 Jul 2024.