Postoperative PainPhase 1/2NCT03398382
Effect of Oral Magnesium on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars.
A Phase 1/2 study testing Magnesium tablet group and Magnesium lozenge group in people with Postoperative Pain and Third Molar, run by Daniel Jerković at 2 sites in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Third Molar, Postoperative Complications
- What is being tested?
- Magnesium tablet group and Magnesium lozenge group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesCroatia
- Study dates
- 15 Apr 2017to 15 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- no analgesics taken in the last 24 hours
- without inflammations in the area
- lower third molars which have an identical position in bone
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites
Clinical Department of Oral Surgery, University Hospital "Dubrava", Zagreb
Zagreb, 10000
University of Zagreb School of Dental Medicine
Zagreb, 10000
About this study
Official title: Effect of Oral Magnesium Supplementation on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars.
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.
Read more
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.
Read the 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.
Drug related risks: allergic reactions, gastrointestinal symptoms (diarrhea). The study will be a double-blind, randomized, split mouth, placebo controlled trial.
It will be carried out with two different oral forms of magnesium citrate:
- in tablet form,
- in the form of a lozenge. Each of these forms will have a same group
1- tablet group, 2-lozenge group. Both of these groups will have a control placebo group. Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX.-Chlorhexidine) will be performed Both sides (over a period of 14 days) will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-articain (1ml injection suspension containing 40mg of articainchloridum and 0.005mg adrenalin in a form of adrenalinchloridium).
For one side, which will be randomly selected, the patient will receive magnesium citrate tablets (Solgar tablets) / lozenges (Diasporal lozenges), and for other placebo tablets / lozenges, which will be identical to the right drug, so the same examinee will be a test and control group. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects regardless of magnesium citrate or placebo group of the same.
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 test is completed. After the surgery, all patients will be given the same written and oral instructions for postoperative care.
The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and magnesium citrate tbl. 200 mg / magnesium citrate lozenges 100 mg or placebo depending on randomized selection.
Magnesium citrate tablets /placebo tablets patients will take 3 days postoperatively so that 400 mg /per day magnesium citrate tbl (Solgar) / placebo will be taken at the same time that will correspond to the time taken for the first tablets, 2 hours preoperatively.
In the group that will use lozenges the patients will take them 30 min. before the procedure a 100 mg. magnesium citrate lozenge (Diasporal) / placebo lozenge 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.
Therapeutic drug doses will be used far below the doses used in the previous studies where the magnesium citrate tablets were used.
During the use of magnesium citrate / placebo (3 days after surgery) the patient will fill out a prepared written questionnaire that will be discussed thoroughly before the first operation.
Postoperative follow-up will be done by the single experienced therapist and by the patient (see Outcome Measures).
The following symptoms which will be assessed are: pain, swelling, maximum inter-incisal opening of mouth, total amount of analgesics taken after surgery, time occurrence and duration of anesthesia and personal experience of pain after surgery (see Outcome Measures). These symptoms will be evaluated on the day of operation and 3 days after surgery.
The planned sample size is at least 40 molars in each group, that is 80 operations in a total of 40 patients using tablets, and equal to the group using lozenges.
- Conditions
- Postoperative Pain, Third Molar, Postoperative Complications
- Being tested
- Magnesium tablet group, Placebo tablets group, Magnesium lozenge group, Placebo lozenges group
- 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
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium tablet groupDietary 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.
Placebo tablets groupDietary 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.
Magnesium lozenge groupDietary 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.
Placebo lozenges groupDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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. Receives: 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) Receives: Dietary Supplement: Placebo lozenges group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: During the first day of operation
Secondary outcomes (2)
Swelling stage 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.
Measured: First 3 days after surgery
Trismus stage after the operative procedure.
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
Measured: First 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start15 Apr 2017
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a double-blind, randomized, split mouth, placebo controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Jerković
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Jerković, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398382
- Sponsor's protocol ID
- 05-PA-15-3/2017
- Status last verified
- Jan 2018
- First submitted
- 7 Jan 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16280233Borazan 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.
PubMed 22797283Wilimzig 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.
PubMed 8857079Nicar 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.
PubMed 6897741Koseoglu E, Talaslioglu A, Gonul AS, Kula M. The effects of magnesium prophylaxis in migraine without aura. Magnes Res. 2008 Jun;21(2):101-8.
PubMed 18705538Bagis 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.
PubMed 22271372Walker 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.
PubMed 14596323Baqain 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.
PubMed 18940492Vormann J. Magnesium: nutrition and metabolism. Mol Aspects Med. 2003 Feb-Jun;24(1-3):27-37. doi: 10.1016/s0098-2997(02)00089-4.
PubMed 12537987Jerkovic 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.
PubMed 32436160
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Magnesium Supplementation on Anesthesia and Postoperative Analgesia After Surgical Removal of the Lower Third Molars.
- ClinicalTrials.gov ID
- NCT03398382
- Acronym / sponsor ID
- 05-PA-15-3/2017
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Daniel JerkovićUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Drug related risks: allergic reactions, gastrointestinal symptoms (diarrhea). The study will be a double-blind, randomized, split mouth, placebo controlled trial.
It will be carried out with two different oral forms of magnesium citrate:
- in tablet form,
- in the form of a lozenge. Each of these forms will have a same group
1- tablet group, 2-lozenge group. Both of these groups will have a control placebo group. Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX.-Chlorhexidine) will be performed Both sides (over a period of 14 days) will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-articain (1ml injection suspension containing 40mg of articainchloridum and 0.005mg adrenalin in a form of adrenalinchloridium).
For one side, which will be randomly selected, the patient will receive magnesium citrate tablets (Solgar tablets) / lozenges (Diasporal lozenges), and for other placebo tablets / lozenges, which will be identical to the right drug, so the same examinee will be a test and control group. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects regardless of magnesium citrate or placebo group of the same.
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 test is completed. After the surgery, all patients will be given the same written and oral instructions for postoperative care.
The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and magnesium citrate tbl. 200 mg / magnesium citrate lozenges 100 mg or placebo depending on randomized selection.
Magnesium citrate tablets /placebo tablets patients will take 3 days postoperatively so that 400 mg /per day magnesium citrate tbl (Solgar) / placebo will be taken at the same time that will correspond to the time taken for the first tablets, 2 hours preoperatively.
In the group that will use lozenges the patients will take them 30 min. before the procedure a 100 mg. magnesium citrate lozenge (Diasporal) / placebo lozenge 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.
Therapeutic drug doses will be used far below the doses used in the previous studies where the magnesium citrate tablets were used.
During the use of magnesium citrate / placebo (3 days after surgery) the patient will fill out a prepared written questionnaire that will be discussed thoroughly before the first operation.
Postoperative follow-up will be done by the single experienced therapist and by the patient (see Outcome Measures).
The following symptoms which will be assessed are: pain, swelling, maximum inter-incisal opening of mouth, total amount of analgesics taken after surgery, time occurrence and duration of anesthesia and personal experience of pain after surgery (see Outcome Measures). These symptoms will be evaluated on the day of operation and 3 days after surgery.
The planned sample size is at least 40 molars in each group, that is 80 operations in a total of 40 patients using tablets, and equal to the group using lozenges.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- The study will be a double-blind, randomized, split mouth, placebo controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Magnesium citrate tablet group | Placebo comparator | Dietary Supplement: Magnesium tablet groupIn 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. |
| Placebo tablet group | Placebo comparator | Dietary Supplement: Placebo tablets groupIn 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) |
| Magnesium citrate lozenge group | Placebo comparator | Dietary Supplement: Magnesium lozenge groupIn 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. |
| Placebo lozenge group | Placebo comparator | Dietary Supplement: Placebo lozenges groupIn 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) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium tablet groupBefore 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. | Dietary supplement | Magnesium citrate tablet group |
| Placebo tablets groupBefore 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. | Dietary supplement | Placebo tablet group |
| Magnesium lozenge groupBefore 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. | Dietary supplement | Magnesium citrate lozenge group |
| Placebo lozenges groupBefore 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. | Dietary supplement | Placebo lozenge group |
Primary outcome
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.
2 secondary outcomes
Swelling stage after surgery
Time frame: First 3 days after surgery
Trismus stage after the operative procedure.
Time frame: First 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Background: PubMed 16280233Colorado-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.
- Background: PubMed 22797283Borazan 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.
- Background: PubMed 8857079Wilimzig 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.
- Background: PubMed 6897741Nicar 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.
- Background: PubMed 18705538Koseoglu E, Talaslioglu A, Gonul AS, Kula M. The effects of magnesium prophylaxis in migraine without aura. Magnes Res. 2008 Jun;21(2):101-8.
- Background: PubMed 22271372Bagis 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.
- Background: PubMed 14596323Walker 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.
- Background: PubMed 18940492Baqain 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.
- Background: PubMed 12537987Vormann J. Magnesium: nutrition and metabolism. Mol Aspects Med. 2003 Feb-Jun;24(1-3):27-37. doi: 10.1016/s0098-2997(02)00089-4.
- Derived from this study: PubMed 32436160Jerkovic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Magnesium tablet group and Magnesium lozenge group in people with Postoperative Pain and Third Molar, run by Daniel Jerković at 2 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: First 3 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398382, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.