Effect of Oral Magnesium Supplementation on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars.
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Pain
Study Overview
Brief Summary
The operation of the lower third molars is one of the most common oral surgery procedures in the world. The surgery is mostly done in local anesthesia which makes the surgery as pleasant as possible for the patient. In addition to anesthesia control, it is also extremely important to insure postoperative pain control since that is the nuisance that patients are most likely to complain about after oral surgery. It has been noticed that magnesium added to local anesthetics can improve and prolong its effect, but also reduce postoperative pain and accelerate recovery. It can also be used as an auxiliary to control pain and inflammation, which is why we will use it in this study, because we have not been able to find magnesium data in the literature for the removal of the lower third molars.
Studies that have already been conducted with oral magnesium are for the purpose of preventing asthma, migraine, for reducing mood swings in PMS, reducing pain after endotracheal intubation, and many others.
Removal by using operative procedure is the only way to remove lower third molars.
The main objective of the study is to demonstrate the influence of the orally received magnesium citrate (before and after surgical removal of the lower third molar) on the quality and duration of the anesthetic block and also its effect on postoperative pain control. Other specific objectives are to investigate the effect of pre/postoperatively received magnesium on:
- swelling stage after surgery.
- time occurrence and duration of anesthesia.
- trismus stage after the operative procedure.
- the total amount of analgetics taken after surgery Benefits for the respondents will be in the assumption that the anesthetic block of the mandibular nerve will last longer with better quality, thus making the surgical procedure more pleasant and that the overall postoperative pain will be lessened and recovery faster in the magnesium citrate group. We also assume that in the magnesium citrate group trismus will be less pronounced and that swelling in postoperative days will be smaller.
Detailed Description
Study design and sample description of this study was performed at the Department of Oral Surgery of Clinical Hospital Dubrava, Zagreb, Croatia.
Respondents are the patients who need to do the operation of both lower third molars and due to this they are in the Clinical Hospital Dubrava. All participants will sign informed consent for participation in the research. Their participation will be voluntary.
The study is approved by Ethics Committee of the School of Dental Medicine, Zagreb, Croatia (03.2017). The identity of the subjects will be protected in all phases of the study.
Respondents in this research will be exposed to the following risks:
Risks related to the procedure: pain, swelling, trismus, inflammation, paresthesia of the mandibular nerve branches (alveolar, lingualis), bleeding.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
The selection of anaesthesia combination with oral placebo or magnesium for each side will be determined by random selection, which will not be known to either the patient or the examiner until the trial is completed.
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Magnesium citrate tablet group
In this group patients will take magnesium citrate tablets 3 days postoperatively, so 400 mg magnesium citrate tbl (Solgar) /per day will be taken at the same time that will correspond to the time the first tablets were taken, 2 hours preoperatively.
Intervention: Magnesium tablet group (Dietary Supplement)
Placebo tablet group
In this group patients will take placebo tablets 3 days postoperatively, so 400 mg /per day placebo tbl will be taken at the same time that will correspond to the time the first tablets were taken, 2 hours preoperatively.
Placebo tablets will be identical to the right drug (Magnesium citrate tbl.Solgar)
Intervention: Placebo tablets group (Dietary Supplement)
Magnesium citrate lozenge group
In this group patients will take 100 mg. magnesium citrate lozenge (Diasporal) 30 min. before the procedure and continue to take up to 4 lozenges per day over the next 3 days in the same time intervals as it was on the day of surgery.
Intervention: Magnesium lozenge group (Dietary Supplement)
Placebo lozenge group
In this group patients will take 100 mg. placebo lozenge 30 min. before the procedure and continue to take up to 4 pastilles per day over the next 3 days in the same time intervals as it was on the day of surgery.
Placebo lozenges will be identical to the right drug (Magnesium citrate tbl.(Diasporal)
Intervention: Placebo lozenges group (Dietary Supplement)
Outcomes
Primary Outcomes
Pain
Time Frame: First 3 days after surgery
Patients will evaluate their postoperative pain with grades from 0-10 according to visual analogue scale (VAS) where the end points were marked as "no pain" (0) and "unbearable pain"(10).
Duration of local anesthesia
Time Frame: During the first day of operation
We will measure the time from the onset of anesthesia activity and the patient will write down when the activity of anesthesia has finished.
Secondary Outcomes
- Trismus stage after the operative procedure.(First 3 days after surgery)
- Swelling stage after surgery(First 3 days after surgery)
Investigators
Daniel Jerković
Principal investigator
University of Zagreb