Alveolar OsteitisNCT07833176
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
A study testing Amoxicillin, Metronidazole and Chlorhexidine in people with Alveolar Osteitis, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This study will compare the effectiveness of amoxicillin, metronidazole, and chlorhexidine in preventing alveolar osteitis (dry socket) following lower third molar extraction. Participants will be randomly assigned to one of three groups: amoxicillin, metronidazole, or chlorhexidine. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- Amoxicillin, Metronidazole and Chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Sep 2026to 20 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 to 40 years.
- Patients requiring non-surgical extraction of impacted or partially erupted mandibular third molars under local anesthesia.
- Patients classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Known allergy or drug hypersensitivity reaction to amoxicillin or metronidazole.
- Patients presenting with active infection at the extraction site, evidenced by pus discharge.
- Periodontally compromised (Grade 1) tooth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Khyber College of Dentistry, Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis Following Lower Third Molar Extraction: A Three-Arm Double-Blinded Randomized Controlled Trial
This study will compare the effectiveness of amoxicillin, metronidazole, and chlorhexidine in preventing alveolar osteitis (dry socket) following lower third molar extraction. Participants will be randomly assigned to one of three groups: amoxicillin, metronidazole, or chlorhexidine. Participants will be assessed on Days 3 and 7 after extraction for the presence or absence of alveolar osteitis and postoperative pain. The study will determine whether there is a difference in the incidence of alveolar osteitis among the three treatment groups.
Read the detailed description
Alveolar osteitis, commonly known as dry socket, is a frequent postoperative complication following lower third molar extraction and may cause significant pain and delayed healing. This study will compare the efficacy of amoxicillin, metronidazole, and chlorhexidine in preventing alveolar osteitis following lower third molar extraction.
This is a three-arm, double-blinded randomized controlled trial to be conducted at the Department of Oral and Maxillofacial Surgery, Khyber College of Dentistry, Peshawar. Patients aged 18-40 years who require extraction of an impacted or partially erupted mandibular third molar under local anesthesia and meet the study eligibility criteria will be considered for participation.
Eligible participants who provide written informed consent will be randomly allocated to one of three groups: Group A will receive amoxicillin, Group B will receive metronidazole, and Group C will receive chlorhexidine as the control intervention. A computer-generated randomization sequence and sequentially numbered, opaque, sealed envelopes will be used for allocation concealment. Placebo tablets and placebo gel will be used to maintain blinding of participants and outcome assessors.
Following extraction, participants will receive standardized postoperative instructions according to their assigned intervention. Participants will be assessed on Days 3 and 7 following extraction. A blinded assessor will evaluate the extraction site for alveolar osteitis using Blum's criteria. The presence or absence of alveolar osteitis will be recorded as a binary outcome. Postoperative pain will also be assessed using a Visual Analogue Scale, and additional postoperative complications or adverse effects will be documented.
The primary objective is to compare the incidence of alveolar osteitis among patients receiving prophylactic amoxicillin, metronidazole, or chlorhexidine following lower third molar extraction. The overall comparison among the three groups will be performed using the Chi-square test, with Fisher's exact test used when appropriate. Planned pairwise comparisons will include amoxicillin versus chlorhexidine, metronidazole versus chlorhexidine, and amoxicillin versus metronidazole, with Bonferroni correction for multiple comparisons.
- Conditions
- Alveolar Osteitis
- Being tested
- Amoxicillin, Metronidazole, Chlorhexidine
- Keywords
- Alveolar osteitis, Molar extraction, Postoperative pain, Dry socket
- Medical subject headings
- Dry Socket, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Amoxicillin will be administered as the prophylactic intervention to participants assigned to the amoxicillin group following lower third molar extraction. Placebo gel will be provided to maintain double blinding.
MetronidazoleDrug
Metronidazole will be administered as the prophylactic intervention to participants assigned to the metronidazole group following lower third molar extraction. Placebo gel will be provided to maintain double blinding.
ChlorhexidineDrug
Chlorhexidine will be administered as the control intervention to participants assigned to the chlorhexidine group following lower third molar extraction. Placebo tablets will be provided to maintain double blinding.
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin Group | Experimental | Participants will receive amoxicillin as the assigned prophylactic intervention following lower third molar extraction. Placebo gel will be provided to maintain double blinding. Receives: Drug: Amoxicillin |
| Metronidazole Group | Experimental | Participants will receive metronidazole as the assigned prophylactic intervention following lower third molar extraction. Placebo gel will be provided to maintain double blinding. Receives: Drug: Metronidazole |
| Chlorhexidine Control Group | Active comparator | Participants will receive chlorhexidine as the control intervention following lower third molar extraction. Placebo tablets will be provided to maintain double blinding. Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Alveolar Osteitis
Alveolar osteitis will be assessed as a binary outcome (yes/no) following lower third molar extraction. The incidence of alveolar osteitis will be compared among the amoxicillin, metronidazole, and chlorhexidine groups.
Measured: Postoperative Day 3 and Day 7
Secondary outcomes (2)
Postoperative Pain
Postoperative pain will be assessed using a Visual Analog Scale (VAS) with mild level (0-3), moderate level (3-7), and severe level(7-10) of pain following lower third molar extraction. Pain scores will be recorded and compared among the three study groups.
Measured: Postoperative Day 3 and Day 7
Complications and Adverse Effects
Complications and adverse effects following lower third molar extraction and administration of the assigned intervention will be assessed and recorded.
Measured: Postoperative Day 3 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alveolar OsteitisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, parallel-group, double-blinded randomized controlled trial comparing amoxicillin, metronidazole, and chlorhexidine for prevention of alveolar osteitis following lower third molar extraction.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber College of dentistry
- Responsible party
- Sponsor
- Investigators
- Danish Khan, BDS*, Principal investigator, Khyber College of dentistryDr Sana Mushtaq, BDS, FCPS, Study director, Khyber College of dentistryDr Syed Muaz Masoom Shah, BDS, MHR, Principal investigator, Khyber College of dentistryDr Braikhna Murad, BDS, FCPS, Principal investigator, Khyber College of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833176
- Sponsor's protocol ID
- KMU/DIR/CTU/2026/13
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be made available to qualified researchers upon reasonable request, subject to applicable ethical, institutional, and data protection requirements. The shared data may include de-identified demographic and clinical characteristics, treatment-group allocation, alveolar osteitis outcomes, postoperative pain scores, and recorded complications or adverse effects.
Publications
Arteagoitia MI, Barbier L, Santamaria J, Santamaria G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.
PubMed 26946211Bergdahl M, Hedstrom L. Metronidazole for the prevention of dry socket after removal of partially impacted mandibular third molar: a randomised controlled trial. Br J Oral Maxillofac Surg. 2004 Dec;42(6):555-8. doi: 10.1016/j.bjoms.2004.06.015.
PubMed 15544888Wright C, Mistry V, Smyth J, Saik WN, Innes N, Lamont T. The use of chlorhexidine in the prevention of alveolar osteitis after third molar extractions. Evid Based Dent. 2018 Mar 23;19(1):18-19. doi: 10.1038/sj.ebd.6401289.
PubMed 29568017Babar A, Ibrahim MW, Baig NJ, Shah I, Amin E. Efficacy of intra-alveolar chlorhexidine gel in reducing frequency of alveolar osteitis in mandibular third molar surgery. J Coll Physicians Surg Pak. 2012 Feb;22(2):91-4.
PubMed 22313644Freudenthal N, Sternudd M, Jansson L, Wannfors K. A double-blind randomized study evaluating the effect of intra-alveolar chlorhexidine gel on alveolar osteitis after removal of mandibular third molars. J Oral Maxillofac Surg. 2015 Apr;73(4):600-5. doi: 10.1016/j.joms.2014.08.035. Epub 2014 Sep 16.
PubMed 25622882Teshome A. The efficacy of chlorhexidine gel in the prevention of alveolar osteitis after mandibular third molar extraction: a systematic review and meta-analysis. BMC Oral Health. 2017 May 19;17(1):82. doi: 10.1186/s12903-017-0376-3.
PubMed 28526078Ramos E, Santamaria J, Santamaria G, Barbier L, Arteagoitia I. Do systemic antibiotics prevent dry socket and infection after third molar extraction? A systematic review and meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Oct;122(4):403-25. doi: 10.1016/j.oooo.2016.04.016. Epub 2016 May 11.
PubMed 27499028
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis Following Lower Third Molar Extraction: A Three-Arm Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07833176
- Acronym / sponsor ID
- KMU/DIR/CTU/2026/13
- Conditions
- Alveolar Osteitis
- Keywords
- Alveolar osteitis, Molar extraction, Postoperative pain, Dry socket
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Khyber College of dentistry
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 22 Sep 2026 (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.
This study will compare the effectiveness of amoxicillin, metronidazole, and chlorhexidine in preventing alveolar osteitis (dry socket) following lower third molar extraction. Participants will be randomly assigned to one of three groups: amoxicillin, metronidazole, or chlorhexidine. Participants will be assessed on Days 3 and 7 after extraction for the presence or absence of alveolar osteitis and postoperative pain. The study will determine whether there is a difference in the incidence of alveolar osteitis among the three treatment groups.
Detailed description
Alveolar osteitis, commonly known as dry socket, is a frequent postoperative complication following lower third molar extraction and may cause significant pain and delayed healing. This study will compare the efficacy of amoxicillin, metronidazole, and chlorhexidine in preventing alveolar osteitis following lower third molar extraction.
This is a three-arm, double-blinded randomized controlled trial to be conducted at the Department of Oral and Maxillofacial Surgery, Khyber College of Dentistry, Peshawar. Patients aged 18-40 years who require extraction of an impacted or partially erupted mandibular third molar under local anesthesia and meet the study eligibility criteria will be considered for participation.
Eligible participants who provide written informed consent will be randomly allocated to one of three groups: Group A will receive amoxicillin, Group B will receive metronidazole, and Group C will receive chlorhexidine as the control intervention. A computer-generated randomization sequence and sequentially numbered, opaque, sealed envelopes will be used for allocation concealment. Placebo tablets and placebo gel will be used to maintain blinding of participants and outcome assessors.
Following extraction, participants will receive standardized postoperative instructions according to their assigned intervention. Participants will be assessed on Days 3 and 7 following extraction. A blinded assessor will evaluate the extraction site for alveolar osteitis using Blum's criteria. The presence or absence of alveolar osteitis will be recorded as a binary outcome. Postoperative pain will also be assessed using a Visual Analogue Scale, and additional postoperative complications or adverse effects will be documented.
The primary objective is to compare the incidence of alveolar osteitis among patients receiving prophylactic amoxicillin, metronidazole, or chlorhexidine following lower third molar extraction. The overall comparison among the three groups will be performed using the Chi-square test, with Fisher's exact test used when appropriate. Planned pairwise comparisons will include amoxicillin versus chlorhexidine, metronidazole versus chlorhexidine, and amoxicillin versus metronidazole, with Bonferroni correction for multiple comparisons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group, double-blinded randomized controlled trial comparing amoxicillin, metronidazole, and chlorhexidine for prevention of alveolar osteitis following lower third molar extraction.
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin Group | Experimental | Drug: AmoxicillinParticipants will receive amoxicillin as the assigned prophylactic intervention following lower third molar extraction. Placebo gel will be provided to maintain double blinding. |
| Metronidazole Group | Experimental | Drug: MetronidazoleParticipants will receive metronidazole as the assigned prophylactic intervention following lower third molar extraction. Placebo gel will be provided to maintain double blinding. |
| Chlorhexidine Control Group | Active comparator | Drug: ChlorhexidineParticipants will receive chlorhexidine as the control intervention following lower third molar extraction. Placebo tablets will be provided to maintain double blinding. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 40 years.
- Patients requiring non-surgical extraction of impacted or partially erupted mandibular third molars under local anesthesia.
- Patients classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Known allergy or drug hypersensitivity reaction to amoxicillin or metronidazole.
- Patients presenting with active infection at the extraction site, evidenced by pus discharge.
- Periodontally compromised (Grade 1) tooth.
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 |
|---|---|---|
| AmoxicillinAmoxicillin will be administered as the prophylactic intervention to participants assigned to the amoxicillin group following lower third molar extraction. Placebo gel will be provided to maintain double blinding. | Drug | Amoxicillin Group |
| MetronidazoleMetronidazole will be administered as the prophylactic intervention to participants assigned to the metronidazole group following lower third molar extraction. Placebo gel will be provided to maintain double blinding. | Drug | Metronidazole Group |
| ChlorhexidineChlorhexidine will be administered as the control intervention to participants assigned to the chlorhexidine group following lower third molar extraction. Placebo tablets will be provided to maintain double blinding. | Drug | Chlorhexidine Control Group |
Primary outcome
Incidence of Alveolar Osteitis
Time frame: Postoperative Day 3 and Day 7
Alveolar osteitis will be assessed as a binary outcome (yes/no) following lower third molar extraction. The incidence of alveolar osteitis will be compared among the amoxicillin, metronidazole, and chlorhexidine groups.
2 secondary outcomes
Postoperative Pain
Time frame: Postoperative Day 3 and Day 7
Complications and Adverse Effects
Time frame: Postoperative Day 3 and Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 26946211Arteagoitia MI, Barbier L, Santamaria J, Santamaria G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.
- Background: PubMed 15544888Bergdahl M, Hedstrom L. Metronidazole for the prevention of dry socket after removal of partially impacted mandibular third molar: a randomised controlled trial. Br J Oral Maxillofac Surg. 2004 Dec;42(6):555-8. doi: 10.1016/j.bjoms.2004.06.015.
- Background: PubMed 29568017Wright C, Mistry V, Smyth J, Saik WN, Innes N, Lamont T. The use of chlorhexidine in the prevention of alveolar osteitis after third molar extractions. Evid Based Dent. 2018 Mar 23;19(1):18-19. doi: 10.1038/sj.ebd.6401289.
- Background: PubMed 22313644Babar A, Ibrahim MW, Baig NJ, Shah I, Amin E. Efficacy of intra-alveolar chlorhexidine gel in reducing frequency of alveolar osteitis in mandibular third molar surgery. J Coll Physicians Surg Pak. 2012 Feb;22(2):91-4.
- Background: PubMed 25622882Freudenthal N, Sternudd M, Jansson L, Wannfors K. A double-blind randomized study evaluating the effect of intra-alveolar chlorhexidine gel on alveolar osteitis after removal of mandibular third molars. J Oral Maxillofac Surg. 2015 Apr;73(4):600-5. doi: 10.1016/j.joms.2014.08.035. Epub 2014 Sep 16.
- Background: PubMed 28526078Teshome A. The efficacy of chlorhexidine gel in the prevention of alveolar osteitis after mandibular third molar extraction: a systematic review and meta-analysis. BMC Oral Health. 2017 May 19;17(1):82. doi: 10.1186/s12903-017-0376-3.
- Background: PubMed 27499028Ramos E, Santamaria J, Santamaria G, Barbier L, Arteagoitia I. Do systemic antibiotics prevent dry socket and infection after third molar extraction? A systematic review and meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Oct;122(4):403-25. doi: 10.1016/j.oooo.2016.04.016. Epub 2016 May 11.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication will be made available to qualified researchers upon reasonable request, subject to applicable ethical, institutional, and data protection requirements. The shared data may include de-identified demographic and clinical characteristics, treatment-group allocation, alveolar osteitis outcomes, postoperative pain scores, and recorded complications or adverse effects.
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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.
Danish Khan, BDS* principal investigator
Khyber College of dentistry
Dr Sana Mushtaq, BDS, FCPS study director
Khyber College of dentistry
Dr Syed Muaz Masoom Shah, BDS, MHR principal investigator
Khyber College of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin, Metronidazole and Chlorhexidine in people with Alveolar Osteitis, run by Khyber Medical University Peshawar 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Sana Mushtaq, BDS, FCPS (+923349249676, sana.mushtaq@kcd.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Alveolar Osteitis (time frame: Postoperative Day 3 and Day 7). 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 NCT07833176, which also lists 7 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 14 Oct 2026.