Not Yet RecruitingPhase 2Phase 3ACTRN12619001349134

The effects of submucosal administration of methylprednisolone and dexamethasone in comparison to control group on pain, swelling, and trismus after third molar surgery

The effectiveness of submucosal administration of methylprednisolone and dexamethasone in comparison to placebo after third molar surgery: a double blinded parallel arm randomized clinical trial


Sponsor

Dr Kinza Ayub

Enrollment

90 participants

Start Date

Oct 15, 2019

Study Type

Interventional

Conditions

Summary

The purpose of the study is to compare the efficacy of submucosal injection of methylprednisolone, dexamethasone and placebo prior to thrid molar extraction.


Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 50 Yearss

Inclusion Criteria3

  • Patients in the age group – 20 to 50 years
  • Patients with mesioangular impactions Class II position B third molar according to the Pell and Gregory’s classification.
  • Patient with no medical conditions

Exclusion Criteria8

  • Patients requiring prophylactic antibiotics before surgical procedure. The following patients will be excluded because taking antibiotic before the treatment will subside the infection and pain and it will act as confounding factor with the study design
  • Patients suffering from any mental disorders or with any chronic pain problems. The following patients will be excluded because of ethical concerns.
  • Pregnant or lactating women. The following patients will be excluded to avoid any harm to pregnancy and fetus.
  • Patients reporting hypersensitivity to steroids. The following patients will be excluded because intervention includes application of steroids and they can have hypersensitivity or anaphylactic reaction
  • Patients taking nonsteroidal anti-inflammatory drugs in the 3 days before participation in the study. The following patients will be excluded because taking NSAIDS before the treatment will subside the infection and pain and it will act as confounding factor with the study design
  • Patients having acute pulpitis, abscesses, or other acute infections. The following patients will be excluded because of ethical concerns.
  • Patients with systemic disorders
  • Patients on long-term steroids

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Interventions

Study will be conducted in oral and maxillofacial ward of Islamic International Dental College Islamabad A double blinded, randomized controlled trial will be carried out. A total of 90 patients w

Study will be conducted in oral and maxillofacial ward of Islamic International Dental College Islamabad A double blinded, randomized controlled trial will be carried out. A total of 90 patients will be included. 25 % patients were added to compensate for the drop out. There will be three groups. Group a will be given submucosal dexamethasone 8 mg once only before the start of the procedure. Group b will be given 40 mg submucosal methyl prednisolone once only and group c will not be given any drug preoperatively and would serve as control group. An independent researcher "I" makes random allocation cards using computer-generated random numbers. He keeps the original random allocation sequences in an inaccessible third place and works with a copy. He will open the envelope for every patient at start of treatment and will tell Dr A that which patient gets what form of intervention. Dr A will give the patient one of two drugs. After this, Dr B will perform the surgical procedure i.e removal of the impacted third molar. Before the start of the surgical procedure patient will be asked the level of pain on the vas score from 1 to 5(1 being very less and 5 being worst). Trismus and mouth opening will be evaluated using the Vernier calipers and measuring the distance between upper and lower teeth. Swelling will be measured by measuring the distance between 4 points. Evaluated by a modification of tape measuring method described by Schultze-Mosgau et al. Two measurements were made between three reference points:Tragus and the corner of the mouth and progonion and center of mouth. The preoperative sum of the two measurements was considered as the baseline for that side. Data analysis would be done through SPSS. A p value of 0.05 will be considered to be arbitrarily significant.


Locations(1)

Pakistan

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ACTRN12619001349134