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Efficacy of tranexamic acid solution irrigation on postoperative sequelae and oral health–related quality of life following mandibular third molar surgery: a randomized controlled trial

Efficacy of tranexamic acid solution irrigation on postoperative sequelae and oral health–related quality of life following mandibular third molar surgery: a randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202508513258189
Enrollment
86
Registered
2025-08-22
Start date
2025-08-19
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

Interventions

Tranexamic acid
Normal saline

Sponsors

Taofeek Akinniyi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • ASA I and II (American Society of Anaesthesiology I) patients i.e. healthy patient with no systemic diseases. • Patients between the ages of 18-40 years • Patients with moderately impacted mandibular third molar (Class I or II, Position A or B) or Pederson’s difficulty index of 5-6 • Patient with no sign of pericoronitis, abscess, or systemic infection • Patient that is willing to participate and provide informed consent

Exclusion criteria

Exclusion criteria: • Presence of bleeding disorders that can lead to uncontrollable post-operative bleeding • Patients on anticoagulant/antiplatelet therapy. These patients are prone to prolong bleeding during and after surgery. • Allergy to tranexamic acid or any study-related medications • Patient on anti-inflammatory or analgesic medications within 48 hours prior to surgery • Patient with previous history of radiation therapy to the head and neck region • Patients with peptic ulcer disease (PUD). The study participants were placed on ibuprofen tablets, 400mg 8 hourly for 3 days after the mandibular third molar surgery. Ibuprofen, a non-steroidal anti-inflammatory drug is contraindicated in peptic ulcer disease patients. • Immunocompromised patients or those with uncontrolled systemic illness • Pregnant or nursing mothers ibuprofen is not totally safe in pregnancy. Ibuprofen is a non-steroidal anti-inflammatory drug and is classified as a US FDA pregnancy category C drug which its use is contraindicated in pregnancy. Ibuprofen is also excreted in breast milk and thus contraindicated in nursing mothers. • Patients with a known allergy to penicillin because subjects will be placed on amoxicillin post-operatively • Patients with a known history of allergy to lignocaine. This is because 2% lignocaine will be used as a local anaesthetic agent. • Patients with acute pericoronitis. This is because surgical extraction of impacted mandibular third molar is contraindicated in areas with acute infection • Patients with pre-operative pain not due to pericoronitis. This is to ensure that post-operative pain measurement is secondary to the procedure. • Patients who smoke. Smoking is known to have an inhibitory effect on wound healing following teeth extraction. • Non consenting patients

Design outcomes

Primary

MeasureTime frame
Postoperative pain, postoperative swelling, postoperative trismus

Secondary

MeasureTime frame
Oral health related quality of life

Countries

Nigeria

Contacts

Public ContactTaofeek Akinniyi

Hospital Consultant

drtaofeek@yahoo.com+2348032492234

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026