Dry Socket Clinical Trial
Official title:
"Prevention of Dry Socket by Means of Single Preoperative Oral Dose of Metronidazole and Amoxicillin Compared to Conventional Therapy"
Verified date | June 2019 |
Source | Dow University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: One of the commonest post-operative complications after tooth extraction is dry
socket; it can be defined as postoperative pain in and around the tooth extraction site,
which increases in severity at any time between 3rd to 5th post-operative days along with
disintegrated blood clot within the tooth extraction socket with or without halitosis. The
exact etiology is unclear therefor prevention remains the main beneficial therapy. Various
factors are thought to play an important role in etiology of dry socket including, anaerobes,
fibrinolysis, traumatic extractions, frequent spiting and rinsing, oral contraceptive pill
and smoking.
Numerous approaches have been tried for prevention of dry socket; include antiseptic
mouthwashes, anti-fibrinolytic agents, antibiotics, intra-socket dressings and medicated
packing into the extraction wound for example chlorohexidine mouthwashes, warm saline rinses,
gelatin sponges, occlusive dressings and oxidized cellulose sponge.
Purpose of the study is to compare the role of single preoperative oral dose of metronidazole
with amoxicillin in hindrance of dry socket compared to conventional therapy after removal of
mandibular third molar of class 2 impaction.
Objectives: To find out effective treatment for prevention of dry socket among preoperative
single oral dose of metronidazole and amoxicillin compared to conventional therapy.
Methods: A double blind randomized control trial in which patients requiring surgical
extraction of lower 3rd molar of class 2 impactions were selected for this study. Patients
were randomly divided into 3 groups, one of the groups had received single preoperative oral
dose of metronidazole one hour before extraction, second group was treated with single oral
dose of amoxicillin an hour before tooth extraction and third group was treated with
conventional therapy. Patients were asked to visit on 5th postoperative day or before it in
case the pain persist or reoccur.
Status | Completed |
Enrollment | 225 |
Est. completion date | April 15, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Patients requiring surgical extraction of lower third molars with class 2 impaction. - Males and females were included. - Age range of the patients was between 18 to 40 years. - Exclusion Criteria: - Non-surgical extractions, extractions of other then lower molars, - Infected tooth. - tooth with grade 3 or greater mobility. - Reluctant to participate. - Pregnant ladies. - Nursing mothers. - Alcoholic patients. - Smokers. - Patients taking oral contraceptives. - Patient already taking antibiotics. - Allergic to amoxicillin and metronidazole. - Patients on anticoagulant therapy i.e. warfarin, nicoumalone, phenytoin, fluocil. - Those with severe renal and hepatic dysfunction. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Dow University of Health Sciences | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Dow University of Health Sciences |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | dry socket | Characteristic of interest: patient complaining of moderate to severe pain in or around the tooth extraction site between 3 to 5 post-operative days. Measuring instruments: The observation will be performed with naked eye under the light of dental unit and cheek will be retracted via dental mirror instrument. Method of testing: Presence of moderate to severe pain, total or incomplete loss of blood clot, bare bone in the socket, and halitosis. Decision criteria: Presence of above features at the site of tooth extraction will indicate the presence of dry socket. |
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