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Effect of Oral Magnesium on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars.

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ClinicalTrials.gov Identifier: NCT03398382
Recruitment Status : Unknown
Verified January 2018 by Daniel Jerković, University of Zagreb.
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Jerković, University of Zagreb

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:

  1. swelling stage after surgery.
  2. time occurrence and duration of anesthesia.
  3. trismus stage after the operative procedure.
  4. 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Third Molar Postoperative Complications Dietary Supplement: Magnesium tablet group Dietary Supplement: Placebo tablets group Dietary Supplement: Magnesium lozenge group Dietary Supplement: Placebo lozenges group Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a double-blind, randomized, split mouth, placebo controlled trial.
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.
Primary Purpose: Supportive Care
Official Title: Effect of Oral Magnesium Supplementation on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars.
Actual Study Start Date : April 15, 2017
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arm Intervention/treatment
Placebo Comparator: 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.
Dietary Supplement: Magnesium tablet group
Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX.) will be performed. Operative side will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-artikain. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects. For one side which will be randomly selected, the patient will receive magnesium citrate tablets. The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and magnesium citrate tablets. 200 mg. After the surgery, all patients will be given the same written and oral instructions for postoperative care.

Placebo Comparator: 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)

Dietary Supplement: Placebo tablets group
Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX.) will be performed. Operative side will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-articain. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects. For one side which will be randomly selected , the patient will receive placebo tablets which will be identical to the right drug. The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and placebo tablets. 200 mg. After the surgery, all patients will be given the same written and oral instructions for postoperative care.

Placebo Comparator: 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.
Dietary Supplement: Magnesium lozenge group
Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX..) will be performed. Operative side will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-articain. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects. For one side which will be randomly selected patient will receive magnesium citrate lozenge.The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and magnesium citrate lozenges. 100 mg. After the surgery, all patients will be given the same written and oral instructions for postoperative care.

Placebo Comparator: 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)

Dietary Supplement: Placebo lozenges group
Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX.) will be performed. Operative side will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-articain. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects. For one side which will be randomly selected patient will receive placebo lozenges which will be identical to the right drug. The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and placebo lozenges 100 mg. After the surgery, all patients will be given the same written and oral instructions for postoperative care.




Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. Swelling stage after surgery [ Time Frame: First 3 days after surgery ]

    The patient will get a prepared written questionnaire that will be discussed thoroughly before the first operation.

    For the swelling we will use a subjective evaluation scale with 4 parameters: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area). Swelling will be determined during the first, second and third postoperative day by the patient.


  2. Trismus stage after the operative procedure. [ Time Frame: First 3 days after surgery ]
    The maximum inter-incisal opening of the mouth was calculated from the mesioincisal angle of the ipsilateral mandibular central incisor to the mesioincisal angle of the ipsilateral mandibular central incisor using the : TheraBite measure


Other Outcome Measures:
  1. Patient's personal experience of the operation [ Time Frame: On the day of operation ]
    Using VAS scale, we will determine the patient's personal experience of the operation



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398382


Locations
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Croatia
Clinical Department of Oral Surgery, University Hospital "Dubrava", Zagreb
Zagreb, Croatia, 10000
University of Zagreb School of Dental Medicine
Zagreb, Croatia, 10000
Sponsors and Collaborators
Daniel Jerković
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Jerković, Principal investigator, University of Zagreb
ClinicalTrials.gov Identifier: NCT03398382    
Other Study ID Numbers: 05-PA-15-3/2017
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Jerković, University of Zagreb:
Magnesium citrate
Trismus after surgical removal of the lower third molars
Local anesthesia
Analgesia after surgical removal of the lower third molars
Swelling after surgical removal of the lower third molars
Surgical removal of the lower third molars
Oral surgical procedures
Placebo effect
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes