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

NCT03398382 | Unknown Phase 1

• 1 other identifier: 05-PA-15-3/2017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Conditions

Postoperative Pain; Third Molar; Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Pain

  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).

  First 3 days after surgery

• Duration of local anesthesia

  We will measure the time from the onset of anesthesia activity and the patient will write down when the activity of anesthesia has finished.

  During the first day of operation

Secondary Outcomes (2)

• Swelling stage after surgery

  First 3 days after surgery

• Trismus stage after the operative procedure.

  First 3 days after surgery

Other Outcomes (1)

• Patient's personal experience of the operation

  On the day of operation

Study Arms (4)

Magnesium citrate tablet group

PLACEBO COMPARATOR

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

Placebo tablet group

PLACEBO COMPARATOR

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

Magnesium citrate lozenge group

PLACEBO COMPARATOR

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

Placebo lozenge group

PLACEBO COMPARATOR

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

Interventions

Magnesium tablet group DIETARY_SUPPLEMENT

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.

Magnesium citrate tablet group

Placebo tablets group DIETARY_SUPPLEMENT

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 tablet group

Magnesium lozenge group DIETARY_SUPPLEMENT

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.

Magnesium citrate lozenge group

Placebo lozenges group DIETARY_SUPPLEMENT

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.

Placebo lozenge group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Jerković: lead

Study Sites (2)

Clinical Department of Oral Surgery, University Hospital "Dubrava", Zagreb

Zagreb, 10000, Croatia

Location

University of Zagreb School of Dental Medicine

Zagreb, 10000, Croatia

Location

Related Publications (10)

• Colorado-Bonnin M, Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Quality of life following lower third molar removal. Int J Oral Maxillofac Surg. 2006 Apr;35(4):343-7. doi: 10.1016/j.ijom.2005.08.008. Epub 2005 Nov 8.

  PMID: 16280233 BACKGROUND

• Borazan H, Kececioglu A, Okesli S, Otelcioglu S. Oral magnesium lozenge reduces postoperative sore throat: a randomized, prospective, placebo-controlled study. Anesthesiology. 2012 Sep;117(3):512-8. doi: 10.1097/ALN.0b013e3182639d5f.

  PMID: 22797283 BACKGROUND

• Wilimzig C, Latz R, Vierling W, Mutschler E, Trnovec T, Nyulassy S. Increase in magnesium plasma level after orally administered trimagnesium dicitrate. Eur J Clin Pharmacol. 1996;49(4):317-23. doi: 10.1007/BF00226334.

  PMID: 8857079 BACKGROUND

• Nicar MJ, Pak CY. Oral magnesium load test for the assessment of intestinal magnesium absorption. Application in control subjects, absorptive hypercalciuria, primary hyperparathyroidism, and hypoparathyroidism. Miner Electrolyte Metab. 1982 Jul;8(1):44-51.

  PMID: 6897741 BACKGROUND

• Koseoglu E, Talaslioglu A, Gonul AS, Kula M. The effects of magnesium prophylaxis in migraine without aura. Magnes Res. 2008 Jun;21(2):101-8.

  PMID: 18705538 BACKGROUND

• Bagis S, Karabiber M, As I, Tamer L, Erdogan C, Atalay A. Is magnesium citrate treatment effective on pain, clinical parameters and functional status in patients with fibromyalgia? Rheumatol Int. 2013 Jan;33(1):167-72. doi: 10.1007/s00296-011-2334-8. Epub 2012 Jan 22.

  PMID: 22271372 BACKGROUND

• Walker AF, Marakis G, Christie S, Byng M. Mg citrate found more bioavailable than other Mg preparations in a randomised, double-blind study. Magnes Res. 2003 Sep;16(3):183-91.

  PMID: 14596323 BACKGROUND

• Baqain ZH, Karaky AA, Sawair F, Khraisat A, Duaibis R, Rajab LD. Frequency estimates and risk factors for postoperative morbidity after third molar removal: a prospective cohort study. J Oral Maxillofac Surg. 2008 Nov;66(11):2276-83. doi: 10.1016/j.joms.2008.06.047.

  PMID: 18940492 BACKGROUND

• Vormann J. Magnesium: nutrition and metabolism. Mol Aspects Med. 2003 Feb-Jun;24(1-3):27-37. doi: 10.1016/s0098-2997(02)00089-4.

  PMID: 12537987 BACKGROUND

• Jerkovic D, Tadin A, Gavic L, Vladislavic NZ, Grgic N, Macan D. Effect of orally administered magnesium on postoperative pain level and trismus after surgical removal of the lower third molars: a randomized, double-blind, placebo-controlled trial. Clin Oral Investig. 2020 Dec;24(12):4649-4659. doi: 10.1007/s00784-020-03335-z. Epub 2020 May 20.

  PMID: 32436160 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study will be a double-blind, randomized, split mouth, placebo controlled trial.

Study Record Dates

• First Submitted: January 7, 2018
• First Posted: January 12, 2018
• Study Start: April 15, 2017
• Primary Completion: December 15, 2018
• Study Completion: June 15, 2019
• Last Updated: October 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CR (2)