|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03398382 |
|
Date of registration:
|
07/01/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Oral Magnesium on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars.
|
|
Scientific title:
|
Effect of Oral Magnesium Supplementation on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars. |
|
Date of first enrolment:
|
April 15, 2017 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Unknown status |
|
URL:
|
https://clinicaltrials.gov/show/NCT03398382 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Croatia
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 18 to 30 years of age (both gender)
- ASA1 (a normal healthy patient)
- Parant 3 (extraction requiring osteotomy and coronal section)
- non-dietary intake
- non-therapeutic
- no magnesium and anaesthetic allergies
- no analgesics taken in the last 24 hours
- without inflammations in the area
- lower third molars which have an identical position in bone
Exclusion Criteria:
- pregnant women
- breastfeeding women
- people on specific nutrition
- people with natural or acquired pathological conditions
- persons known for drug abuse analgesics or any kind of drugs
- patients who will use antibiotics or another drugs during postoperative recovery
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Third Molar
|
|
Postoperative Complications
|
|
Postoperative Pain
|
|
Intervention(s)
|
|
Dietary Supplement: Placebo lozenges group
|
|
Dietary Supplement: Magnesium lozenge group
|
|
Dietary Supplement: Magnesium tablet group
|
|
Dietary Supplement: Placebo tablets group
|
|
Primary Outcome(s)
|
|
Duration of local anesthesia
[Time Frame: During the first day of operation]
|
|
Pain
[Time Frame: First 3 days after surgery]
|
|
Secondary Outcome(s)
|
|
Swelling stage after surgery
[Time Frame: First 3 days after surgery]
|
|
Trismus stage after the operative procedure.
[Time Frame: First 3 days after surgery]
|
|
Secondary ID(s)
|
|
05-PA-15-3/2017
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|