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Not yet recruitingNCT07894016Updated Oct 26, 2026

Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction

A Phase 4 interventional study of Amoxicillin 2g and Clindamycin 600 mg in Wisdom Tooth Removal, Antibiotic Prophylaxis and Single Dose, sponsored by Dow University of Health Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Dow University of Health Sciences · Phase 4, Interventional, and Prevention

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.
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

02

Conditions studied

  • Wisdom Tooth Removal
  • Antibiotic Prophylaxis
  • Single Dose

Keywords

  • Single dose Antibiotic Prophylaxis
  • Amoxicillin
  • Clindamycin
  • Azithromycin
  • Comparison
  • Third Molar Extraction
03

In context

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 176 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Lactating mothers
  • People who have any soft tissue healing disorder
  • Patient undergone radiotherapy
  • Patient having kidney or liver disease
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
105 participants (estimated)

Study arms

  • Active comparator
    Amoxicillin

    This Group will receive Amoxicillin Single dose

    Drug: Amoxicillin 2g

  • Active comparator
    Clindamycin

    This Group will receive Clindamycin Single dose

    Drug: Clindamycin 600 mg

  • Active comparator
    Azithromycin

    This group will receive Azithromycin Single dose

    Drug: Azithromycin 500mg

Interventions

  • DrugAmoxicillin 2g

    single dose

  • Single dose

  • DrugAzithromycin 500mg

    Single dose

06

What researchers measure

Primary outcomes

  1. No. of Participants with Dry Socket

    Alveolar Osteitis, sharp pain accompanied by smell and absence of blood clot. Reported as yes or no

    Time frame: from baseline pre-surgery to third day post-surgery

  2. No. of Participants with Surgical Site Infection

    Surgical Site infection presence of post-operative granulation tissue or non-healing, reported as yes or no

    Time frame: from baseline pre-surgery to third day post-surgery

Secondary outcomes

  1. No. of Participants with Trismus

    Inability to open jaw till normal mouth opening range

    Time frame: from baseline pre-surgery to third day post-surgery

  2. 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.

    Time frame: from baseline pre-surgery to third day post-surgery

  3. No. of Participants with Bleeding

    Presence and absence of Bleeding

    Time frame: from baseline pre-surgery to third day post-surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

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 36508534 ↗
  • Gazal 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 35409861 ↗
  • Gabidullina 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 35760661 ↗
  • Zafar, 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 30145064 ↗
  • Yoshida 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 32007386 ↗
  • Sigron 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 25342545 ↗
  • Rodrigues 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 25279397 ↗
  • Pourmand 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 25342640 ↗
  • Monaco 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 19531419 ↗
  • Martin 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 15789086 ↗
  • Marghalani 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 24789242 ↗
  • Lee 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 24029441 ↗
  • Kirnbauer 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 ↗
  • Kiencalo A, Jamka-Kasprzyk M, Panas M, Wyszynska-Pawelec G. Analysis of complications after the removal of 339 third molars. Dent Med Probl. 2021 Jan-Mar;58(1):75-80. doi: 10.17219/dmp/127028. PubMed 33789003 ↗
  • Karemore TV, Ashtankar KA, Motwani M. Comparative efficacy of pre-operative and post-operative administration of amoxicillin in third molar extraction surgery - A systematic review and meta-analysis. Natl J Maxillofac Surg. 2024 Jan-Apr;15(1):29-35. doi: 10.4103/njms.njms_163_22. Epub 2024 Mar 19. PubMed 38690250 ↗
  • Cervino G, Cicciu M, Biondi A, Bocchieri S, Herford AS, Laino L, Fiorillo L. Antibiotic Prophylaxis on Third Molar Extraction: Systematic Review of Recent Data. Antibiotics (Basel). 2019 May 2;8(2):53. doi: 10.3390/antibiotics8020053. PubMed 31052566 ↗
  • Camps-Font O, Sabado-Bundo H, Toledano-Serrabona J, Valmaseda-de-la-Rosa N, Figueiredo R, Valmaseda-Castellon E. Antibiotic prophylaxis in the prevention of dry socket and surgical site infection after lower third molar extraction: a network meta-analysis. Int J Oral Maxillofac Surg. 2024 Jan;53(1):57-67. doi: 10.1016/j.ijom.2023.08.001. Epub 2023 Aug 21. PubMed 37612199 ↗

Study documents

  • Protocol, analysis plan and consent form · Aug 17, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD that's used for results publication

Supporting information: Study protocol, Informed consent form

Time frame: December 2026- December 2027

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07894016
Responsible party
Meer Muhammad Fawad (Principal Investigator, Dow University of Health Sciences) — Principal investigator
First posted
Oct 26, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Oct 26, 2026

Study contacts

Meer M Fawad, Masters of Science
Contact
fawadshaikh55@gmail.com
+923331255251
Meer M Fawad, Masters of Science
principal investigator · Down University of Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Clindamycin

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