Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456060
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Efficacy of Pure Honey Dressing in Contrast to Alvogyl in the Resolution of Dry Socket
Sponsor:
Watim Medical Dental College
Organization:
Watim Medical Dental College
Study Overview
Official Title:
Exploring the Efficacy of Pure Honey Dressing in Contrast to Alvogyl in the Resolution of Dry Socket A Comparative Analysis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 However due to Alvogyls 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
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
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None