Wisdom Tooth RemovalPhase 4NCT07894016
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
A Phase 4 study testing Amoxicillin 2g, Clindamycin 600 mg and Azithromycin 500mg in people with Wisdom Tooth Removal and Antibiotic Prophylaxis, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn which drug amongst Amoxicillin, Clindamycin and Azithromycin single dose works better in reducing post-surgical complications in Participants getting lower wisdom teeth pulled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wisdom Tooth Removal, Antibiotic Prophylaxis, Single Dose
- What is being tested?
- Amoxicillin 2g, Clindamycin 600 mg and Azithromycin 500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2026to 30 Dec 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with no history antibiotics for past 1 month
- No active infection going
- No allergies to any antibiotics, analgesics, local anesthetic
- Cases of low to medium difficulty
- Age bracket from 18 years or older
Who cannot join
- Pregnant women
- Lactating mothers
- People who have any soft tissue healing disorder
- Patient undergone radiotherapy
- Patient having kidney or liver disease
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, 1 recruiting
- Recruiting
Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences
Karachi, Sindh, 75330
Meer Fawad
About this study
Official title: Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction, A Randomized Control Trial
The goal of this clinical trial is to learn which drug amongst Amoxicillin, Clindamycin and Azithromycin single dose works better in reducing post-surgical complications in Participants getting lower wisdom teeth pulled. The main question it aims to answer is:
- Which single dose drug lowers the post-surgical complications in participants of this study? Researcher will compare three single dose drugs (the administration of the complete amount of an antibiotic medication in one single administration to cure or prevent an infection).
Read more
Participants will:
- Take provided drug one hour before the treatment
- Visit the OPD for Reading measurements same day before the surgery, same day after the surgery and third day after the surgery.
Read the detailed description
In this Clinical Trial, Principal Investigator is comparing three single dose antibiotic drugs by comparing post-operative outcomes of Lower third molar extraction (Wisdom Tooth getting pulled).
After checking for Participant's eligibility. Participants will be asked for their consent to be part of research and then Initial Baseline reading will be measured and then they will be given medication and will be asked to take it and wait for an hour.
After Surgery, once participant is calmed down Investigators will wait for 25-30mins and will record 2nd set of readings to check the effect of surgery on pain, mouth opening, bleeding.
After Surgery day 3 participant will be called for follow-up that's when third set of readings will be measured.
Post Data Collection Data Analysis will be done using SPSS 21
- Conditions
- Wisdom Tooth Removal, Antibiotic Prophylaxis, Single Dose
- Being tested
- Amoxicillin 2g, Clindamycin 600 mg, Azithromycin 500mg
- Keywords
- Single dose Antibiotic Prophylaxis, Amoxicillin, Clindamycin, Azithromycin, Comparison, Third Molar Extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin 2gDrug
single dose
Clindamycin 600 mgDrug
Single dose
Azithromycin 500mgDrug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Active comparator | This Group will receive Amoxicillin Single dose Receives: Drug: Amoxicillin 2g |
| Clindamycin | Active comparator | This Group will receive Clindamycin Single dose Receives: Drug: Clindamycin 600 mg |
| Azithromycin | Active comparator | This group will receive Azithromycin Single dose Receives: Drug: Azithromycin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
No. of Participants with Dry Socket
Alveolar Osteitis, sharp pain accompanied by smell and absence of blood clot. Reported as yes or no
Measured: from baseline pre-surgery to third day post-surgery
No. of Participants with Surgical Site Infection
Surgical Site infection presence of post-operative granulation tissue or non-healing, reported as yes or no
Measured: from baseline pre-surgery to third day post-surgery
Secondary outcomes (3)
No. of Participants with Trismus
Inability to open jaw till normal mouth opening range
Measured: from baseline pre-surgery to third day post-surgery
Mean and Standard Deviation of Pain Score
Pain Score measured on Likert scale. Where low score means less pain and higher score means more pain.
Measured: from baseline pre-surgery to third day post-surgery
No. of Participants with Bleeding
Presence and absence of Bleeding
Measured: from baseline pre-surgery to third day post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start20 Oct 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Wisdom Tooth RemovalStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meer Muhammad Fawad, Dow University of Health Sciences
- Investigators
- Meer M Fawad, Masters of Science, Principal investigator, Down University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894016
- Sponsor's protocol ID
- 4717/DUHS/Approval/2026/359
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that's used for results publication
Publications
Daley JO, Brizuela M. Antibiotic Prophylaxis in Dental and Oral Surgery Practice. 2026 Feb 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK587360/
PubMed 36508534Gazal G, Al-Samadani KH, Alsaidalani HM, Karbouji GA, Alharbi AM. A Comparison of Pre-Emptive Co-Amoxiclav, Postoperative Amoxicillin, and Metronidazole for Prevention of Postoperative Complications in Dentoalveolar Surgery: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Mar 31;19(7):4178. doi: 10.3390/ijerph19074178.
PubMed 35409861Gabidullina VR, Tsitsiashvili AM, Volkov AV, Stankova NV, Zaborovsky AV, Tsarev VN, Panin AM, Podporina VV. Comprehensive assessment of dental implant procedures: a comparative study on different antibiotic prophylaxis regimens. Parodontologiya. 2024;29(2):113-126
Remschmidt B, Schwaiger M, Gaessler J, Wallner J, Zemann W, Schwaiger M. Surgical site infections in orthognathic surgery: prolonged versus single-dose antibiotic prophylaxis. Int J Oral Maxillofac Surg. 2023 Feb;52(2):219-226. doi: 10.1016/j.ijom.2022.06.002. Epub 2022 Jun 25.
PubMed 35760661Zafar, K. J., Saleh, M. I., Khurram, M., Janjua, O. S., Mustafa Ch, M., Saeed, A., & Akhtar, M. U. (2019). ROLE OF PREOPERATIVE ANTIBIOTICS IN PREVENTION OF POSTOPERATIVE INFECTION AFTER IMPACTED MANDIBULAR THIRD MOLAR SURGERY. Pakistan Oral & Dental Journal, 39(1), 43-46.
Menon RK, Gopinath D, Li KY, Leung YY, Botelho MG. Does the use of amoxicillin/amoxicillin-clavulanic acid in third molar surgery reduce the risk of postoperative infection? A systematic review with meta-analysis. Int J Oral Maxillofac Surg. 2019 Feb;48(2):263-273. doi: 10.1016/j.ijom.2018.08.002. Epub 2018 Aug 23.
PubMed 30145064Yoshida H, Matsuda S, Aratani T, Tsukamoto H, Yoshimura H, Sano K, Iwasaki H. Collaboration with an infection control team promoted appropriate antibiotic use for third molar extraction at a Japanese hospital. J Infect Chemother. 2020 Jun;26(6):531-534. doi: 10.1016/j.jiac.2020.01.003. Epub 2020 Jan 30.
PubMed 32007386Sigron GR, Pourmand PP, Mache B, Stadlinger B, Locher MC. The most common complications after wisdom-tooth removal: part 1: a retrospective study of 1,199 cases in the mandible. Swiss Dent J. 2014;124(10):1042-6, 1052-6. doi: 10.61872/sdj-2014-10-01. English, German.
PubMed 25342545Rodrigues WC, Okamoto R, Pellizzer EP, dos Carrijo AC, de Almeida RS, de Melo WM. Antibiotic prophylaxis for third molar extraction in healthy patients: Current scientific evidence. Quintessence Int. 2015 Feb;46(2):149-61. doi: 10.3290/j.qi.a32825.
PubMed 25279397Pourmand PP, Sigron GR, Mache B, Stadlinger B, Locher MC. The most common complications after wisdom-tooth removal: part 2: a retrospective study of 1,562 cases in the maxilla. Swiss Dent J. 2014;124(10):1047-51. doi: 10.61872/sdj-2014-10-02. English, German.
PubMed 25342640Monaco G, Tavernese L, Agostini R, Marchetti C. Evaluation of antibiotic prophylaxis in reducing postoperative infection after mandibular third molar extraction in young patients. J Oral Maxillofac Surg. 2009 Jul;67(7):1467-72. doi: 10.1016/j.joms.2008.12.066.
PubMed 19531419Martin MV, Kanatas AN, Hardy P. Antibiotic prophylaxis and third molar surgery. Br Dent J. 2005 Mar 26;198(6):327-30. doi: 10.1038/sj.bdj.4812170.
PubMed 15789086Marghalani A. Antibiotic prophylaxis reduces infectious complications but increases adverse effects after third-molar extraction in healthy patients. J Am Dent Assoc. 2014 May;145(5):476-8. doi: 10.14219/jada.2013.51. No abstract available.
PubMed 24789242Lee JY, Do HS, Lim JH, Jang HS, Rim JS, Kwon JJ, Lee ES. Correlation of antibiotic prophylaxis and difficulty of extraction with postoperative inflammatory complications in the lower third molar surgery. Br J Oral Maxillofac Surg. 2014 Jan;52(1):54-7. doi: 10.1016/j.bjoms.2013.08.010. Epub 2013 Sep 9.
PubMed 24029441Kirnbauer B, Jakse N, Truschnegg A, Dzidic I, Mukaddam K, Payer M. Is perioperative antibiotic prophylaxis in the case of routine surgical removal of the third molar still justified? A randomized, double-blind, placebo-controlled clinical trial with a split-mouth design. Clin Oral Investig. 2022 Oct;26(10):6409-6421. doi: 10.1007/s00784-022-04597-5. Epub 2022 Jul 6.
PubMed 35792962
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction, A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07894016
- Acronym / sponsor ID
- 4717/DUHS/Approval/2026/359
- Conditions
- Wisdom Tooth Removal, Antibiotic Prophylaxis, Single Dose
- Keywords
- Single dose Antibiotic Prophylaxis, Amoxicillin, Clindamycin, Azithromycin, Comparison, Third Molar Extraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Oct 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.
The goal of this clinical trial is to learn which drug amongst Amoxicillin, Clindamycin and Azithromycin single dose works better in reducing post-surgical complications in Participants getting lower wisdom teeth pulled. The main question it aims to answer is:
- Which single dose drug lowers the post-surgical complications in participants of this study? Researcher will compare three single dose drugs (the administration of the complete amount of an antibiotic medication in one single administration to cure or prevent an infection).
Participants will:
- Take provided drug one hour before the treatment
- Visit the OPD for Reading measurements same day before the surgery, same day after the surgery and third day after the surgery.
Detailed description
In this Clinical Trial, Principal Investigator is comparing three single dose antibiotic drugs by comparing post-operative outcomes of Lower third molar extraction (Wisdom Tooth getting pulled).
After checking for Participant's eligibility. Participants will be asked for their consent to be part of research and then Initial Baseline reading will be measured and then they will be given medication and will be asked to take it and wait for an hour.
After Surgery, once participant is calmed down Investigators will wait for 25-30mins and will record 2nd set of readings to check the effect of surgery on pain, mouth opening, bleeding.
After Surgery day 3 participant will be called for follow-up that's when third set of readings will be measured.
Post Data Collection Data Analysis will be done using SPSS 21
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Active comparator | Drug: Amoxicillin 2gThis Group will receive Amoxicillin Single dose |
| Clindamycin | Active comparator | Drug: Clindamycin 600 mgThis Group will receive Clindamycin Single dose |
| Azithromycin | Active comparator | Drug: Azithromycin 500mgThis group will receive Azithromycin Single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with no history antibiotics for past 1 month
- No active infection going
- No allergies to any antibiotics, analgesics, local anesthetic
- Cases of low to medium difficulty
- Age bracket from 18 years or older
Key exclusion criteria (5 listed)
- Pregnant women
- Lactating mothers
- People who have any soft tissue healing disorder
- Patient undergone radiotherapy
- Patient having kidney or liver disease
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 |
|---|---|---|
| Amoxicillin 2gsingle dose | Drug | Amoxicillin |
| Clindamycin 600 mgSingle dose | Drug | Clindamycin |
| Azithromycin 500mgSingle dose | Drug | Azithromycin |
Primary outcome
No. of Participants with Dry Socket
Time frame: from baseline pre-surgery to third day post-surgery
Alveolar Osteitis, sharp pain accompanied by smell and absence of blood clot. Reported as yes or no
No. of Participants with Surgical Site Infection
Time frame: from baseline pre-surgery to third day post-surgery
Surgical Site infection presence of post-operative granulation tissue or non-healing, reported as yes or no
3 secondary outcomes
No. of Participants with Trismus
Time frame: from baseline pre-surgery to third day post-surgery
Mean and Standard Deviation of Pain Score
Time frame: from baseline pre-surgery to third day post-surgery
No. of Participants with Bleeding
Time frame: from baseline pre-surgery to third day post-surgery
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 2 Nov 2026.
- Background: PubMed 36508534Daley JO, Brizuela M. Antibiotic Prophylaxis in Dental and Oral Surgery Practice. 2026 Feb 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK587360/
- Background: PubMed 35409861Gazal G, Al-Samadani KH, Alsaidalani HM, Karbouji GA, Alharbi AM. A Comparison of Pre-Emptive Co-Amoxiclav, Postoperative Amoxicillin, and Metronidazole for Prevention of Postoperative Complications in Dentoalveolar Surgery: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Mar 31;19(7):4178. doi: 10.3390/ijerph19074178.
- BackgroundGabidullina VR, Tsitsiashvili AM, Volkov AV, Stankova NV, Zaborovsky AV, Tsarev VN, Panin AM, Podporina VV. Comprehensive assessment of dental implant procedures: a comparative study on different antibiotic prophylaxis regimens. Parodontologiya. 2024;29(2):113-126
- Background: PubMed 35760661Remschmidt B, Schwaiger M, Gaessler J, Wallner J, Zemann W, Schwaiger M. Surgical site infections in orthognathic surgery: prolonged versus single-dose antibiotic prophylaxis. Int J Oral Maxillofac Surg. 2023 Feb;52(2):219-226. doi: 10.1016/j.ijom.2022.06.002. Epub 2022 Jun 25.
- BackgroundZafar, K. J., Saleh, M. I., Khurram, M., Janjua, O. S., Mustafa Ch, M., Saeed, A., & Akhtar, M. U. (2019). ROLE OF PREOPERATIVE ANTIBIOTICS IN PREVENTION OF POSTOPERATIVE INFECTION AFTER IMPACTED MANDIBULAR THIRD MOLAR SURGERY. Pakistan Oral & Dental Journal, 39(1), 43-46.
- Background: PubMed 30145064Menon RK, Gopinath D, Li KY, Leung YY, Botelho MG. Does the use of amoxicillin/amoxicillin-clavulanic acid in third molar surgery reduce the risk of postoperative infection? A systematic review with meta-analysis. Int J Oral Maxillofac Surg. 2019 Feb;48(2):263-273. doi: 10.1016/j.ijom.2018.08.002. Epub 2018 Aug 23.
- Background: PubMed 32007386Yoshida H, Matsuda S, Aratani T, Tsukamoto H, Yoshimura H, Sano K, Iwasaki H. Collaboration with an infection control team promoted appropriate antibiotic use for third molar extraction at a Japanese hospital. J Infect Chemother. 2020 Jun;26(6):531-534. doi: 10.1016/j.jiac.2020.01.003. Epub 2020 Jan 30.
- Background: PubMed 25342545Sigron GR, Pourmand PP, Mache B, Stadlinger B, Locher MC. The most common complications after wisdom-tooth removal: part 1: a retrospective study of 1,199 cases in the mandible. Swiss Dent J. 2014;124(10):1042-6, 1052-6. doi: 10.61872/sdj-2014-10-01. English, German.
- Background: PubMed 25279397Rodrigues WC, Okamoto R, Pellizzer EP, dos Carrijo AC, de Almeida RS, de Melo WM. Antibiotic prophylaxis for third molar extraction in healthy patients: Current scientific evidence. Quintessence Int. 2015 Feb;46(2):149-61. doi: 10.3290/j.qi.a32825.
- Background: PubMed 25342640Pourmand PP, Sigron GR, Mache B, Stadlinger B, Locher MC. The most common complications after wisdom-tooth removal: part 2: a retrospective study of 1,562 cases in the maxilla. Swiss Dent J. 2014;124(10):1047-51. doi: 10.61872/sdj-2014-10-02. English, German.
- Background: PubMed 19531419Monaco G, Tavernese L, Agostini R, Marchetti C. Evaluation of antibiotic prophylaxis in reducing postoperative infection after mandibular third molar extraction in young patients. J Oral Maxillofac Surg. 2009 Jul;67(7):1467-72. doi: 10.1016/j.joms.2008.12.066.
- Background: PubMed 15789086Martin MV, Kanatas AN, Hardy P. Antibiotic prophylaxis and third molar surgery. Br Dent J. 2005 Mar 26;198(6):327-30. doi: 10.1038/sj.bdj.4812170.
- In this study, researchers compare pre-operative Single dose amoxicillin cover with no antibiotic cover. results indicates significant reduction in infection rate among individual in Pre-operative Antibiotic Cover Group.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD that's used for results publication
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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.
Meer M Fawad, Masters of Science principal investigator
Down University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin 2g, Clindamycin 600 mg and Azithromycin 500mg in people with Wisdom Tooth Removal and Antibiotic Prophylaxis, run by Dow University of Health Sciences 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Meer M Fawad, Masters of Science (+923331255251, fawadshaikh55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No. of Participants with Dry Socket (time frame: from baseline pre-surgery to third day post-surgery). The study lists 2 primary outcomes in all. 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 NCT07894016, which also lists 19 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 2 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.