Efficacy of Ibuprofen Chronotherapy in Healing After Surgical Extraction of the Mandibular Third Molar

NCT03789058 | Unknown Phase 2 DMC

• 1 other identifier: 20170307
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical and preclinical studies have demonstrated encouraging results of non-steroidal anti-inflammatory drug (NSAID) chronotherapy in the management and treatment of inflammatory diseases such as rheumatoid arthritis. However, no previous clinical trials have addressed how the timing of NSAID administration within the day affects pain and healing outcomes after oral surgery that involves bone removal, such as surgical extraction of the third molars. Methods to address our aim, Single-center double-blind randomized controlled trial study design has been adopted. Patients who needed a lower third molar extraction and meet the eligibility criteria will be recruited. Participants will be randomized into two groups. Subjects in group one will be instructed to take an NSAID (ibuprofen 400 mg) at 7 AM and 12 PM combined with a placebo before bed between 8 and 10 PM for three days postoperatively. Subjects in group 2 will be instructed to take an NSAID (ibuprofen 400 mg) between 7 AM, 12 PM and between 8 and 10 PM for three days postoperatively. The patients' self-reported pain in the three days after surgery will be recorded as the primary outcome. Additionally, healing indicators such as the maximum interincisal distance and measurements of facial swelling will be recorded preoperatively and four days postoperatively. Each participant's blood level of C-reactive protein will be recorded pre- and postoperatively as an inflammatory marker. Discussion: The study will estimate the effect of using NSAID only in the morning following surgical extraction of the third molar to decrease pain and improve postoperative healing and recovery in comparison to the routine use of NSAIDs three times per day.

Conditions

Operation Site Inflammation; Pain, Postoperative; Teeth, Impacted

Outcome Measures

Primary Outcomes (1)

• Pain Measurement

  Measuring of post operative pain severity according to Visual Analogue Scale healing indicators such as edema and mouth opening .

  four days measurement of VAS

Secondary Outcomes (2)

• Inflammation Degree Measurement

  Pre-Op, 4th day after operation

• Facial Swelling and mouth opening measuring

  pre-op, 4th day post op.

Study Arms (2)

Surgical with conventional NSAID 3 times/day

ACTIVE COMPARATOR

Control group will have surgical intervention to remove wisdom tooth and receive conventional NSAID treatment three times per day

Drug: Ibuprofen 400 mg

Surgical with conventional NSAID 2 times/days

EXPERIMENTAL

The experimental group will have surgival intervention to remove wisdom tooth and receive NSAID treatment only two times per day: once after breakfast and once after lunch, but not at night.

Drug: Ibuprofen 400 mg

Interventions

Ibuprofen 400 mg DRUG

Surgical removal of wisdom teethb with different regimen of Ibuprofen frequency ; three times versus two times .

Also known as: Advil, Motrin

Surgical with conventional NSAID 2 times/days; Surgical with conventional NSAID 3 times/day

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (i) be aged between 18 and 35 years old
• (ii) be healthy according to the American Society of Anesthesiologists (ASA) classification (subject should not have an active infection, trismus, hyperthermia, or swelling before surgery and must be able to maintain adequate oral hygiene)
• (iii) have an adequate understanding of written and spoken English or Arabic to fill out a questionnaire,
• (iv) be capable of signing an informed consent form
• (vi) third molar surgical extraction, the indicated teeth should be lower third molars and partially or completely impacted

You may not qualify if:

• (i) have a history of systemic diseases (e.g., diabetes mellitus, hypertension, gastric ulcer)
• (ii) have a severe/serious illness that requires frequent hospitalization
• (iii) are current smokers
• (iv) are pregnant or breastfeeding
• (v) are taking antinflammtory or analgesic drugs in the previous two weeks or are allergic to NSAIDs
• (vi) have impaired cognitive or motor function
• (vii) are unable to return for evaluations/study recalls.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead
• McGill University: collaborator
• InterPharma One LLC: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Tooth, Impacted

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Zaid Z Tamimi, HSD

  JUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaid Z Tamimi, HSD

CONTACT

00962795036670; zztamimi@just.edu.jo

Ala M Abu Roqaa, M.SC.

CONTACT

00962795052394; director@interpharma-1.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The treatment regimens were masked for both participants and care provider (Clinical investigator)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment a single-center double-blind randomized controlled trial

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: December 28, 2018
• Study Start: April 19, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)