A Phase 1 interventional study of Alvogyl and Honey in Dry Socket, sponsored by Watim Medical & Dental College. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Watim Medical & Dental College · Phase 1, Interventional, and Treatment
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.
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:
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)
46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 41 interventional studies indexed under Dry Socket.
Browse Dry Socket studies →Watim Medical & Dental College is the lead sponsor of 12 studies on the registry; 9 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In Control Group, after flushing the socket with normal saline a gauze soaked with Alvogyl will be used to cover the socket..
Drug: Alvogyl
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.
Drug: Honey
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..
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.
Plan to share: No
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Studies of the drug tested here: Honey
Watim Medical & Dental College