Chlorhexidine Versus Normal Saline Socket Irrigation for Prevention of Dry Socket After Lower Wisdom Tooth Extraction (CHX-AO)
Comparison of the Effect of Immediate Post-Extraction Socket Irrigation With Normal Saline Versus Chlorhexidine on the Frequency of Dry Socket: A Single-Blinded Randomized Controlled Trial
Dry socket, also called alveolar osteitis, is a painful complication that can occur after tooth extraction, particularly following removal of impacted lower wisdom teeth. It occurs when the blood clot that normally forms in the extraction socket is lost or breaks down, resulting in pain and delayed healing.
This study will compare two solutions used to irrigate the extraction socket immediately after removal of an impacted lower wisdom tooth: normal saline and chlorhexidine. The study will determine whether immediate socket irrigation with chlorhexidine reduces the frequency of dry socket compared with normal saline.
A total of 174 eligible patients undergoing surgical extraction of impacted lower wisdom teeth will be randomly assigned to receive either normal saline or chlorhexidine for immediate post-extraction socket irrigation. Participants will not be informed which irrigation solution they receive. The extraction will be performed by a single surgeon, and postoperative assessment will be performed by a co-researcher.
Participants will be assessed for signs and symptoms of dry socket on postoperative days 2, 3, and 5. The occurrence of dry socket will be determined using predefined clinical criteria, including pain, trismus, halitosis, gingival inflammation, exposed or bare bone, radiating pain, and ipsilateral lymphadenopathy.
The study will compare the frequency of dry socket between the chlorhexidine and normal saline groups. The findings may help determine whether chlorhexidine is more effective than normal saline for reducing the occurrence of dry socket after surgical extraction of impacted lower wisdom teeth.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Alveolar osteitis, commonly known as dry socket, is a painful postoperative complication that may occur following tooth extraction. It is characterised by moderate to severe pain at the extraction site and may be associated with delayed healing and other local clinical signs. The condition generally develops within the first few days following extraction and may cause considerable discomfort to patients.
The development of alveolar osteitis has been associated with breakdown or loss of the blood clot within the extraction socket. Local fibrinolytic activity and bacterial factors have been proposed as contributing mechanisms. Surgical trauma, bacterial contamination and other patient- and procedure-related factors may increase the risk of alveolar osteitis.
Normal saline is commonly used for irrigation of extraction sockets after surgical tooth removal. Chlorhexidine has antimicrobial and antiseptic properties and has been investigated for its potential role in reducing the occurrence of alveolar osteitis. Previous studies have reported lower frequencies of dry socket following chlorhexidine use compared with saline or other postoperative measures. However, the effectiveness of immediate post-extraction socket irrigation with chlorhexidine compared with normal saline requires further evaluation in the local clinical setting.
This single-blinded randomized controlled trial will compare the effect of immediate post-extraction socket irrigation with chlorhexidine versus normal saline on the frequency of dry socket following surgical extraction of impacted lower wisdom teeth.
Eligible patients will be recruited from the Oral and Maxillofacial Surgery Department, CMH Medical College and Institute of Dentistry, Lahore. Participants will be adults aged 18-50 years who are classified as ASA physical status I or II and who require surgical extraction of impacted lower wisdom teeth with slight to moderate difficulty according to Pederson's scale.
After informed consent is obtained, eligible participants will be randomly allocated to one of two treatment groups using a lottery method. One group will receive immediate irrigation of the extraction socket with chlorhexidine, while the other group will receive immediate irrigation with normal saline. The allocated irrigation solution will be applied after completion of the tooth extraction and before closure of the extraction socket. The extraction procedure will be performed by a single surgeon under local anaesthesia.
Participants will remain unaware of the irrigation solution allocated to them. Postoperative assessment will be performed by a co-researcher to reduce the potential for assessment bias. Standard postoperative instructions and postoperative medications will be provided according to the study protocol.
Participants will be evaluated on postoperative days 2, 3, and 5 for clinical features of alveolar osteitis. Dry socket will be diagnosed when at least three predefined diagnostic criteria are present. The criteria include mild to severe pain, trismus, halitosis, an inflamed or hyperaemic gingival area, exposed or bare bone with an empty socket, radiating pain to the ear or temporal region, and ipsilateral lymphadenopathy.
Trismus will be assessed by measuring the maximum inter-incisal distance in millimetres. A value below 35 mm will be considered indicative of trismus.
The primary purpose of the study is to determine whether immediate post-extraction socket irrigation with chlorhexidine reduces the frequency of alveolar osteitis compared with normal saline. The findings may provide evidence regarding the effectiveness of chlorhexidine as an alternative to normal saline for immediate socket irrigation following surgical extraction of impacted lower wisdom teeth.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lahore, Pakistan
- CMH Lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 50 years.
- Patients requiring surgical extraction of an impacted lower third molar (lower wisdom tooth).
- Impacted lower third molars classified as having slight to moderate difficulty according to Pederson's scale.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Patients of either biological sex.
- Patients who provide written informed consent to participate in the study.
Exclusion Criteria:
- Systolic blood pressure ≥160 mmHg.
- Diastolic blood pressure ≥100 mmHg.
- Current smokers.
- Alcohol use.
- Patients with muscular diseases.
- Patients currently taking antibiotics or anti-inflammatory medications.
- Patients with physical or mental disabilities that would prevent participation in the study or completion of follow-up assessments.
- Patients requiring extraction without bony osteotomy.
- Deep or very difficult impactions according to Pederson's scale.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chlorhexidine Socket Irrigation
Participants allocated to the experimental group will undergo surgical extraction of an impacted lower third molar under local anaesthesia.
Immediately after extraction, the extraction socket will be irrigated with chlorhexidine according to the study protocol, followed by socket closure with silk suture.
Participants will receive the same postoperative instructions and medications as the comparator group.
Postoperative assessment for alveolar osteitis will be performed on days 2, 3, and 5.
|
Immediate post-extraction irrigation of the surgical extraction socket with chlorhexidine following removal of an impacted lower third molar.
The allocated chlorhexidine solution will be applied immediately after extraction and before socket closure with silk suture.
The extraction will be performed under local anaesthesia by a single surgeon.
The concentration and volume of chlorhexidine will be administered according to the study protocol.
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|
Active Comparator: Normal Saline Socket Irrigation
Participants allocated to the comparator group will undergo surgical extraction of an impacted lower third molar under local anaesthesia.
Immediately after extraction, the extraction socket will be irrigated with normal saline according to the study protocol, followed by socket closure with silk suture.
Participants will receive the same postoperative instructions and medications as the experimental group.
Postoperative assessment for alveolar osteitis will be performed on days 2, 3, and 5.
|
Immediate post-extraction irrigation of the surgical extraction socket with normal saline following removal of an impacted lower third molar.
The allocated normal saline solution will be applied immediately after extraction and before socket closure with silk suture.
The extraction will be performed under local anaesthesia by a single surgeon.
The volume of normal saline will be administered according to the study protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frequency of Alveolar Osteitis (Dry Socket)
Time Frame: Postoperative days 2, 3, and 5
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The frequency of alveolar osteitis (dry socket) will be assessed in participants following surgical extraction of an impacted lower third molar.
Alveolar osteitis will be diagnosed when at least three predefined clinical criteria are present, including mild to severe postoperative pain, trismus, halitosis, inflamed or hyperaemic gingiva, exposed or bare bone with an empty socket, radiating pain to the ear or temporal region, and ipsilateral lymphadenopathy.
The number and percentage of participants developing alveolar osteitis will be compared between the chlorhexidine and normal saline groups.
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Postoperative days 2, 3, and 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Pain Intensity
Time Frame: Postoperative days 2, 3, and 5
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Postoperative pain will be assessed using a Visual Analogue Scale (VAS).
Pain intensity will be recorded during postoperative assessment and compared between the chlorhexidine and normal saline groups.
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Postoperative days 2, 3, and 5
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Postoperative Trismus
Time Frame: Postoperative days 2, 3, and 5
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Trismus will be assessed by measuring the maximum inter-incisal distance in millimetres using a ruler.
An inter-incisal distance of less than 35 mm will be considered indicative of trismus.
Measurements will be compared between the chlorhexidine and normal saline groups.
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Postoperative days 2, 3, and 5
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMHL-OMFS-AO-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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