Pain, PostoperativePhase 4NCT06160180
Comparative Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone on Postoperative Complications Following Surgical Extraction of Mandibular Third Molar: Randomized Controlled Trial
A Phase 4 study testing Dexamethasone in people with Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences.
Trial summary
The goal of this study is to compare the pain, edema and trismus of pre-operative versus post-operative submucosal dexamethasone in lower third molar surgical extraction done in healthy population.This is comparative study, will be conducted in patient indicated for surgical extraction of mandibular third molar at the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2024
- Phase
- Phase 4
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically healthy patients (American Society of Anesthesiology I) with impacted lower third molar.
- Age ≥18 to ≤ 55 years
- No history of previous pericoronitis
Who cannot join
- • Patients who are ASA II to ASA VI.
- Patients already on corticosteriods through any route.
- Patients with known allergy to any drugs.
- Pregnant and lactating females
- Patient not consenting to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Trial on Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone On Postoperative Complications Following Surgical Extraction Of Mandibular Third Molar.
The goal of this study is to compare the pain, edema and trismus of pre-operative versus post-operative submucosal dexamethasone in lower third molar surgical extraction done in healthy population.This is comparative study, will be conducted in patient indicated for surgical extraction of mandibular third molar at the department of oral and maxillofacial surgery, college of dental surgery, BPKIHS, Nepal. Verbal and written informed consent will be taken. Participants meeting inclusion criteria will be included in the study and will be divided into two groups, group A(pre-operative submucosal 2ml of 4mg/ml dexamethasone will be administered prior to placing an incision in buccal vestibule) and groupB(post-operative submucosal 2ml of 4mg/ml dexamethasone will be administered soon after closure of the incision site).Baseline measurement of interincisal distance for mouth opening, distance between the tragus to corner of mouth, gonion to corner of mouth and outer canthus to gonion as baseline for edema taken prior extraction. Extraction is carried out using standard protocol and postoperative antibiotics and analgesics are given. Rescue analgesic tramadol is prescribed and asked to be taken only pain score exceeds 7.Patient is kept on follow up for 2nd, 5th and 7th days and assessment of pain using numeric visual analogue scale, swelling using facial and trismus using interincial measurements and recorded. Any adverse effect of drugs will be recorded. The data collected will be entered in Microsoft excel sheet. It will then be transferred into SPSS(Statistical package for Social Sciences) for statistical analysis.
Read the detailed description
Introduction:Third molar impaction is a chronic disorder that often necessitates tooth extraction. Impaction is characterized as the inability of a tooth to erupt at its proper location in the dental arch during its usual growth time.The surgical extraction of lower third molars is the most frequent intervention in oral surgery. This procedure is often associated with significant postsurgical sequelae that may have both biological and social impact. Besides severe complications such as dysaesthesia, severe infection, fracture, and dry socket, patients frequently complain of pain, swelling, and limitation in mouth opening (Trismus) throughout the postoperative course due to the inflammatory response following the surgical injury. To control postoperative inflammation and symptoms associated, it is necessary to provide an adequate anti-inflammatory therapy and various medications have been prescribed for the same. For several decades surgeons administered corticosteroids before or just after third molars' surgery to reduce inflammation and associated symptoms after oral surgery. Corticosteroids mechanism of action is the inhibition of the enzyme Phospholipase A2 (PLA 2), which reduces the release of arachidonic acid in the cells of the inflamed area.This will decrease prostaglandins and leukotriene synthesis; therefore reducing the accumulation of neutrophils has been the greatest advantage of corticosteroids compared to non-steroidal anti-inflammatory drugs. The aim of this study was to evaluate the effect of preoperative versus postoperative administration of submucosal Dexamethasone on postoperative discomfort including pain, edema, and trismus following lower third molar surgery in order to allow a better welfare of the patient and to return the patient to the normal activity following the surgery. And to determine the efficacy of single dose 2 ml/8 mg submucosal dexamethasone injection in the buccal vestibule in proximity to the surgical site.
Rational:Pain and edema are the most frequent postoperative sequelae to surgical removal of impacted teeth, all of which are due to the local inflammatory response. The inflammation induced by tissue damage is the primary cause of acute postoperative pain after third molar extraction. Edema after third molar surgery is caused by extravasation of fluid by traumatized tissues as a consequence of the disruption or obstruction of lymph arteries, culminating in the termination of lymph drainage, which accumulates in the tissues. Adjunctive use of corticosteroids to decrease tissue mediators of inflammation and reduce fluid transudation and edema is common in surgical procedures. Corticosteroids inhibits the enzyme Phospholipase A2 (PLA 2), which reduces the release of arachidonic acid in the cells of the inflamed area.Dexamethasone has higher potency, lower sodium retaining ability and longer half-life. Long-acting steroids outperform short-acting steroids, and submucosal steroid administration has similar consequences as intravenous and intramuscular routes. Also rate of absorption is highly dependent on the blood flow to the site.Submucosal dexamethasone is quite simple, less invasive, painless, convenient for the surgeon and the patient and offers a low cost solution for the typical discomfort associated with the extraction of impacted lower third molar. Also,submucosal injection offers advantage of concentrating the drug near the surgical area with less systemic absorption and no further manipulation of the tissues.
- Conditions
- Pain, Postoperative
- Being tested
- Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called treatment
Submucosal application
| Study group | Role | What they receive |
|---|---|---|
| Drug arm preoperative | Active comparator | Injection 2ml of 4mg dexamethasone loaded and deposited submucosally in the buccal vestibule of the extraction site after local anesthesia but before placement of the first incision. Receives: Drug: Dexamethasone |
| Drug arm postoperative | Active comparator | Injection 2ml of 4mg dexamethasone loaded and deposited submucosallyin the buccal vestibule of the extraction site after finishing extraction and placement of last suture. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN MEASUREMENT POSTOPERATIVELY AFTER SURGICAL EXTRACTION OF 3RD MOLAR
Pain will be calculated through Visual analogue Scale with 1 being least painful and 10 being most painful. Each patient fter extraction will be instructed for follow up in 2nd 5th and 7th postoperative days and asked to give value for the pain they experienced.
Number of analgesics consumed was also counted from 2nd postoperative day to 7th postoperative day and will be recorded in written logbook.
Number of resucue analgesics: if in case of severe pain not relieved by prescribed analgesic(Tab paracetamol+ ibuprofen), Cap tramadol is prescribed if necessary and was recorded in each postoperative days and written in the log book.
Measured: SECOND, FIFTH AND SEVENTH POST OPERATIVE DAY
SWELING
facial measurements through graduated measuring tape in centimeters (outer canthus to gonion, tragus of ear to corner of mouth and corner of mouth to gonion
Measured: BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY
TRISMUS
MEASURING NON-FORCED INTERINCISAL DISTANCE THROUGH STANDARD MEASURING SCALE IN MILIMETERS
Measured: BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study startAug 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shristi Maharjan, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160180
- Sponsor's protocol ID
- IRC/2508/023
- Status last verified
- Aug 2024
- First submitted
- 29 Nov 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lau AAL, De Silva RK, Thomson M, De Silva H, Tong D. Third Molar Surgery Outcomes: A Randomized Clinical Trial Comparing Submucosal and Intravenous Dexamethasone. J Oral Maxillofac Surg. 2021 Feb;79(2):295-304. doi: 10.1016/j.joms.2020.09.020. Epub 2020 Sep 17.
PubMed 33058774Saravanan K, Kannan R, John RR, Nantha Kumar C. A Single Pre Operative Dose of Sub Mucosal Dexamethasone is Effective in Improving Post Operative Quality of Life in the Surgical Management of Impacted Third Molars: A Comparative Randomised Prospective Study. J Maxillofac Oral Surg. 2016 Mar;15(1):67-71. doi: 10.1007/s12663-015-0795-0. Epub 2015 May 26.
PubMed 26929555Al-Shamiri HM, Shawky M, Hassanein N. Comparative Assessment of Preoperative versus Postoperative Dexamethasone on Postoperative Complications following Lower Third Molar Surgical Extraction. Int J Dent. 2017;2017:1350375. doi: 10.1155/2017/1350375. Epub 2017 Apr 10.
PubMed 28487738Deo SP. Effect of submucosal injection of dexamethasone on post-operative sequelae of third molar surgery. JNMA J Nepal Med Assoc. 2011 Apr-Jun;51(182):72-8.
PubMed 22916516Majid OW, Mahmood WK. Effect of submucosal and intramuscular dexamethasone on postoperative sequelae after third molar surgery: comparative study. Br J Oral Maxillofac Surg. 2011 Dec;49(8):647-52. doi: 10.1016/j.bjoms.2010.09.021. Epub 2010 Oct 29.
PubMed 21035237Bhargava D, Sreekumar K, Deshpande A. Effects of intra-space injection of Twin mix versus intraoral-submucosal, intramuscular, intravenous and per-oral administration of dexamethasone on post-operative sequelae after mandibular impacted third molar surgery: a preliminary clinical comparative study. Oral Maxillofac Surg. 2014 Sep;18(3):293-6. doi: 10.1007/s10006-013-0412-7. Epub 2013 Mar 20.
PubMed 23512235Almeida RAC, Lemos CAA, de Moraes SLD, Pellizzer EP, Vasconcelos BC. Efficacy of corticosteroids versus placebo in impacted third molar surgery: systematic review and meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2019 Jan;48(1):118-131. doi: 10.1016/j.ijom.2018.05.023. Epub 2018 Jun 23.
PubMed 29941229
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone On Postoperative Complications Following Surgical Extraction Of Mandibular Third Molar.
- ClinicalTrials.gov ID
- NCT06160180
- Acronym / sponsor ID
- IRC/2508/023
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Dec 2023 (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 goal of this study is to compare the pain, edema and trismus of pre-operative versus post-operative submucosal dexamethasone in lower third molar surgical extraction done in healthy population.This is comparative study, will be conducted in patient indicated for surgical extraction of mandibular third molar at the department of oral and maxillofacial surgery, college of dental surgery, BPKIHS, Nepal. Verbal and written informed consent will be taken. Participants meeting inclusion criteria will be included in the study and will be divided into two groups, group A(pre-operative submucosal 2ml of 4mg/ml dexamethasone will be administered prior to placing an incision in buccal vestibule) and groupB(post-operative submucosal 2ml of 4mg/ml dexamethasone will be administered soon after closure of the incision site).Baseline measurement of interincisal distance for mouth opening, distance between the tragus to corner of mouth, gonion to corner of mouth and outer canthus to gonion as baseline for edema taken prior extraction. Extraction is carried out using standard protocol and postoperative antibiotics and analgesics are given. Rescue analgesic tramadol is prescribed and asked to be taken only pain score exceeds 7.Patient is kept on follow up for 2nd, 5th and 7th days and assessment of pain using numeric visual analogue scale, swelling using facial and trismus using interincial measurements and recorded. Any adverse effect of drugs will be recorded. The data collected will be entered in Microsoft excel sheet. It will then be transferred into SPSS(Statistical package for Social Sciences) for statistical analysis.
Detailed description
Introduction:Third molar impaction is a chronic disorder that often necessitates tooth extraction. Impaction is characterized as the inability of a tooth to erupt at its proper location in the dental arch during its usual growth time.The surgical extraction of lower third molars is the most frequent intervention in oral surgery. This procedure is often associated with significant postsurgical sequelae that may have both biological and social impact. Besides severe complications such as dysaesthesia, severe infection, fracture, and dry socket, patients frequently complain of pain, swelling, and limitation in mouth opening (Trismus) throughout the postoperative course due to the inflammatory response following the surgical injury. To control postoperative inflammation and symptoms associated, it is necessary to provide an adequate anti-inflammatory therapy and various medications have been prescribed for the same. For several decades surgeons administered corticosteroids before or just after third molars' surgery to reduce inflammation and associated symptoms after oral surgery. Corticosteroids mechanism of action is the inhibition of the enzyme Phospholipase A2 (PLA 2), which reduces the release of arachidonic acid in the cells of the inflamed area.This will decrease prostaglandins and leukotriene synthesis; therefore reducing the accumulation of neutrophils has been the greatest advantage of corticosteroids compared to non-steroidal anti-inflammatory drugs. The aim of this study was to evaluate the effect of preoperative versus postoperative administration of submucosal Dexamethasone on postoperative discomfort including pain, edema, and trismus following lower third molar surgery in order to allow a better welfare of the patient and to return the patient to the normal activity following the surgery. And to determine the efficacy of single dose 2 ml/8 mg submucosal dexamethasone injection in the buccal vestibule in proximity to the surgical site.
Rational:Pain and edema are the most frequent postoperative sequelae to surgical removal of impacted teeth, all of which are due to the local inflammatory response. The inflammation induced by tissue damage is the primary cause of acute postoperative pain after third molar extraction. Edema after third molar surgery is caused by extravasation of fluid by traumatized tissues as a consequence of the disruption or obstruction of lymph arteries, culminating in the termination of lymph drainage, which accumulates in the tissues. Adjunctive use of corticosteroids to decrease tissue mediators of inflammation and reduce fluid transudation and edema is common in surgical procedures. Corticosteroids inhibits the enzyme Phospholipase A2 (PLA 2), which reduces the release of arachidonic acid in the cells of the inflamed area.Dexamethasone has higher potency, lower sodium retaining ability and longer half-life. Long-acting steroids outperform short-acting steroids, and submucosal steroid administration has similar consequences as intravenous and intramuscular routes. Also rate of absorption is highly dependent on the blood flow to the site.Submucosal dexamethasone is quite simple, less invasive, painless, convenient for the surgeon and the patient and offers a low cost solution for the typical discomfort associated with the extraction of impacted lower third molar. Also,submucosal injection offers advantage of concentrating the drug near the surgical area with less systemic absorption and no further manipulation of the tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug arm preoperative | Active comparator | Drug: DexamethasoneInjection 2ml of 4mg dexamethasone loaded and deposited submucosally in the buccal vestibule of the extraction site after local anesthesia but before placement of the first incision. |
| Drug arm postoperative | Active comparator | Drug: DexamethasoneInjection 2ml of 4mg dexamethasone loaded and deposited submucosallyin the buccal vestibule of the extraction site after finishing extraction and placement of last suture. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinically healthy patients (American Society of Anesthesiology I) with impacted lower third molar.
- Age ≥18 to ≤ 55 years
- No history of previous pericoronitis
Key exclusion criteria (5 listed)
- • Patients who are ASA II to ASA VI.
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 |
|---|---|---|
| DexamethasoneAlso: treatmentSubmucosal application | Drug | Drug arm postoperative, Drug arm preoperative |
Primary outcome
PAIN MEASUREMENT POSTOPERATIVELY AFTER SURGICAL EXTRACTION OF 3RD MOLAR
Time frame: SECOND, FIFTH AND SEVENTH POST OPERATIVE DAY
Pain will be calculated through Visual analogue Scale with 1 being least painful and 10 being most painful. Each patient fter extraction will be instructed for follow up in 2nd 5th and 7th postoperative days and asked to give value for the pain they experienced. Number of analgesics consumed was also counted from 2nd postoperative day to 7th postoperative day and will be recorded in written logbook. Number of resucue analgesics: if in case of severe pain not relieved by prescribed analgesic(Tab paracetamol+ ibuprofen), Cap tramadol is prescribed if necessary and was recorded in each postoperative days and written in the log book.
SWELING
Time frame: BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY
facial measurements through graduated measuring tape in centimeters (outer canthus to gonion, tragus of ear to corner of mouth and corner of mouth to gonion
TRISMUS
Time frame: BASELINE,SECOND, FIFTH AND SEVENTH POSTOPERATIVE DAY
MEASURING NON-FORCED INTERINCISAL DISTANCE THROUGH STANDARD MEASURING SCALE IN MILIMETERS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 33058774Lau AAL, De Silva RK, Thomson M, De Silva H, Tong D. Third Molar Surgery Outcomes: A Randomized Clinical Trial Comparing Submucosal and Intravenous Dexamethasone. J Oral Maxillofac Surg. 2021 Feb;79(2):295-304. doi: 10.1016/j.joms.2020.09.020. Epub 2020 Sep 17.
- Background: PubMed 26929555Saravanan K, Kannan R, John RR, Nantha Kumar C. A Single Pre Operative Dose of Sub Mucosal Dexamethasone is Effective in Improving Post Operative Quality of Life in the Surgical Management of Impacted Third Molars: A Comparative Randomised Prospective Study. J Maxillofac Oral Surg. 2016 Mar;15(1):67-71. doi: 10.1007/s12663-015-0795-0. Epub 2015 May 26.
- Background: PubMed 28487738Al-Shamiri HM, Shawky M, Hassanein N. Comparative Assessment of Preoperative versus Postoperative Dexamethasone on Postoperative Complications following Lower Third Molar Surgical Extraction. Int J Dent. 2017;2017:1350375. doi: 10.1155/2017/1350375. Epub 2017 Apr 10.
- Background: PubMed 22916516Deo SP. Effect of submucosal injection of dexamethasone on post-operative sequelae of third molar surgery. JNMA J Nepal Med Assoc. 2011 Apr-Jun;51(182):72-8.
- Background: PubMed 21035237Majid OW, Mahmood WK. Effect of submucosal and intramuscular dexamethasone on postoperative sequelae after third molar surgery: comparative study. Br J Oral Maxillofac Surg. 2011 Dec;49(8):647-52. doi: 10.1016/j.bjoms.2010.09.021. Epub 2010 Oct 29.
- Background: PubMed 23512235Bhargava D, Sreekumar K, Deshpande A. Effects of intra-space injection of Twin mix versus intraoral-submucosal, intramuscular, intravenous and per-oral administration of dexamethasone on post-operative sequelae after mandibular impacted third molar surgery: a preliminary clinical comparative study. Oral Maxillofac Surg. 2014 Sep;18(3):293-6. doi: 10.1007/s10006-013-0412-7. Epub 2013 Mar 20.
- Background: PubMed 29941229Almeida RAC, Lemos CAA, de Moraes SLD, Pellizzer EP, Vasconcelos BC. Efficacy of corticosteroids versus placebo in impacted third molar surgery: systematic review and meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2019 Jan;48(1):118-131. doi: 10.1016/j.ijom.2018.05.023. Epub 2018 Jun 23.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences.
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 3 inclusion and 5 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Shristi Maharjan, MDS (9841981841, shreemaharjan93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAIN MEASUREMENT POSTOPERATIVELY AFTER SURGICAL EXTRACTION OF 3RD MOLAR (time frame: SECOND, FIFTH AND SEVENTH POST OPERATIVE DAY). The study lists 3 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 NCT06160180, which also lists 7 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 9 Aug 2024.