Impacted Third MolarNCT07436546
Prospective Evaluation of Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: a Split Mouth Randomized Study
A study testing Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline) and 2% lignocaine with adr (1:2,00,000) in people with Impacted Third Molar and Impacted Third Molar Tooth, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The aim of this study is to evaluate the efficacy of tumescent solution on post operative sequalae in patients treated for surgical removal of impacted lower third molar. The objectives are Primary Objective 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar, Impacted Third Molar Tooth, Third Molar Extraction
- What is being tested?
- Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline) and 2% lignocaine with adr (1:2,00,000)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 23 Mar 2025to 23 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria - ASA Class I subjects aged over 18 years presenting with bilateral impacted mandibular third molars of similar difficulty indices.
Exclusion Criteria: - Existence of acute infection and/or swelling and pain at the time of surgery with systemic disorders or history of complications associated with local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the efficacy of tumescent solution on post operative sequalae in patients treated for surgical removal of impacted lower third molar. The objectives are
Primary Objective
Read more
- To evaluate post-operative pain severity after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration.
Secondary objectives
- To evaluate post-operative trismus after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration
- To evaluate post operative swelling after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration
Read the detailed description
Title
Prospective Evaluation of the Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: A Split-Mouth Randomized Controlled Clinical Trial
Background and Rationale
Surgical removal of impacted mandibular third molars is one of the most frequently performed procedures in oral and maxillofacial surgery. Despite being routine, it is commonly associated with postoperative complications such as pain, facial swelling (edema), and trismus. These sequelae typically peak within the first 24-48 hours and significantly affect patient comfort, oral hygiene, mastication, and quality of life.
Corticosteroids have been widely used via systemic and local routes to minimize postoperative inflammatory morbidity. Submucosal and intramuscular dexamethasone have demonstrated significant reductions in postoperative edema and pain; however, optimal delivery technique remains under investigation.
Tumescent anesthesia, originally developed for liposuction, involves infiltration of a dilute solution containing local anesthetic, vasoconstrictor, and adjunct agents to produce tissue tumescence. This technique enhances hemostasis, prolongs anesthesia, and may reduce inflammatory sequelae. While tumescent anesthesia has been explored in plastic, dermatologic, and orthognathic surgery, its role in impacted mandibular third molar surgery remains inadequately studied.
Therefore, this study was designed to evaluate the efficacy of tumescent steroid infiltration as an adjunct to conventional local anesthesia in reducing postoperative pain, swelling, and trismus following mandibular third molar surgery.
Study Objectives Primary Objective
To evaluate postoperative pain severity following surgical removal of impacted mandibular third molars using:
2% lidocaine with adrenaline alone versus 2% lidocaine with adrenaline combined with tumescent steroid infiltration
Secondary Objectives
- To compare postoperative facial swelling between the two interventions.
- To compare postoperative trismus (maximum interincisal mouth opening).
Study Design
Type of Study: Prospective, randomized, double-blind, split-mouth controlled clinical trial
Study Setting: Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak, Haryana, India
Blinding: Double-blind (Patient and outcome assessor blinded)
In the split-mouth design, each patient served as their own control. One side was randomly assigned to receive conventional local anesthesia (control), and the contralateral side received local anesthesia with adjunctive tumescent steroid infiltration (test).
- Conditions
- Impacted Third Molar, Impacted Third Molar Tooth, Third Molar Extraction, Third Molar Extraction Surgery
- Being tested
- Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline), 2% lignocaine with adr (1:2,00,000)
- Keywords
- impacted third molar, tumescent solution, third molar surgery, disimpaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline)Drug
A 15 mL tumescent solution containing dexamethasone (8 mg), bupivacaine, adrenaline (1:1000 dilution), hyaluronidase (1500 IU), and normal saline was administered via submucosal infiltration after standard inferior alveolar nerve block using 2% lidocaine with adrenaline (1:2,00,000). The solution was injected at the mucogingival junction on the buccal aspect of the mandibular molars and into the loose distal submucosa adjacent to the impacted third molar prior to surgical extraction. The intervention aimed to reduce postoperative inflammatory sequelae including pain, swelling, and trismus.
2% lignocaine with adr (1:2,00,000)Drug
Standard inferior alveolar nerve block, lingual nerve block, and long buccal nerve infiltration were administered using 2% lidocaine with adrenaline (1:2,00,000). No adjunctive steroid or tumescent infiltration was used in this arm. Surgical removal of the impacted mandibular third molar was performed using a standardized technique including mucoperiosteal flap elevation, bone guttering, tooth sectioning when required, irrigation, and suturing. Postoperative medications and follow-up protocol were identical to the test group.
| Study group | Role | What they receive |
|---|---|---|
| Tumescent Steroid Infiltration with 2% Lidocaine and Adrenaline in Mandibular Third Molar | Experimental | Participants received 2% lidocaine with adrenaline (1:2,00,000) using standard nerve block techniques. In addition, a 15 ml tumescent steroid solution was infiltrated submucosally after local anesthesia administration, targeting the mucogingival junction on the buccal aspect and the loose distal submucosa adjacent to the third molar.
The tumescent solution comprised normal saline, bupivacaine, dexamethasone (8 mg), hyaluronidase (1500 IU), and adrenaline (1:1000 dilution). Surgical removal was then performed using the same standardized technique as in the control arm. Postoperative medications and instructions were identical to the control arm. Receives: Drug: Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline) |
| Conventional 2% Lidocaine with Adrenaline in Mandibular Third Molar Surgery | Active comparator | Participants received 2% lidocaine with adrenaline (1:2,00,000) administered via standard inferior alveolar nerve block, lingual nerve block, and long buccal nerve infiltration. No adjunctive anti-inflammatory or tumescent infiltration was administered. Surgical removal of the impacted mandibular third molar was performed using a standardized technique (Ward's/Modified Ward's flap, bone guttering with surgical bur, tooth sectioning when required, irrigation, and suturing). Postoperative medications and instructions were identical to the test arm. Receives: Drug: 2% lignocaine with adr (1:2,00,000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Severity Following Mandibular Third Molar Surgery
Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. Pain scores will be recorded at immediate postoperative period and on postoperative Day 1, Day 2, and Day 7. The primary endpoint will be the difference in mean VAS pain scores between the control (2% lidocaine with adrenaline alone) and test (2% lidocaine with adrenaline plus tumescent steroid infiltration) sites, with particular emphasis on postoperative Day 1, when peak inflammatory pain is expected.
Measured: Immediate postoperative period, Postoperative Day 1, Day 2, and Day 7
Secondary outcomes (1)
Postoperative Facial Swelling and Trismus Following Mandibular Third Molar Surgery
Postoperative facial swelling will be measured using standardized linear facial measurements between fixed anatomical landmarks (lateral canthus to gonion, tragus to pogonion, and tragus to angle of mouth) using a flexible measuring scale. Trismus will be assessed by measuring maximum interincisal mouth opening (in millimeters). Measurements will be recorded preoperatively and on postoperative Day 1, Day 2, and Day 7. Intergroup comparisons will be performed between the control (2% lidocaine with adrenaline alone) and test (2% lidocaine with adrenaline plus tumescent steroid infiltration) sites.
Measured: Preoperative baseline, Postoperative Day 1, Day 2, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Mar 2025
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third MolarStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Virendra Singh, MDS, Study director, PGIDS ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436546
- Sponsor's protocol ID
- Aanand Niwas Mishra
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: a Split Mouth Randomized Study
- ClinicalTrials.gov ID
- NCT07436546
- Acronym / sponsor ID
- Aanand Niwas Mishra
- Conditions
- Impacted Third Molar, Impacted Third Molar Tooth, Third Molar Extraction, Third Molar Extraction Surgery
- Keywords
- impacted third molar, tumescent solution, third molar surgery, disimpaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 27 Feb 2026 (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 aim of this study is to evaluate the efficacy of tumescent solution on post operative sequalae in patients treated for surgical removal of impacted lower third molar. The objectives are
Primary Objective
- To evaluate post-operative pain severity after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration.
Secondary objectives
- To evaluate post-operative trismus after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration
- To evaluate post operative swelling after surgical removal of impacted lower 3rd molar under Lidocaine 2% with adrenaline with and without Tumescent steroid infiltration
Detailed description
Title
Prospective Evaluation of the Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: A Split-Mouth Randomized Controlled Clinical Trial
Background and Rationale
Surgical removal of impacted mandibular third molars is one of the most frequently performed procedures in oral and maxillofacial surgery. Despite being routine, it is commonly associated with postoperative complications such as pain, facial swelling (edema), and trismus. These sequelae typically peak within the first 24-48 hours and significantly affect patient comfort, oral hygiene, mastication, and quality of life.
Corticosteroids have been widely used via systemic and local routes to minimize postoperative inflammatory morbidity. Submucosal and intramuscular dexamethasone have demonstrated significant reductions in postoperative edema and pain; however, optimal delivery technique remains under investigation.
Tumescent anesthesia, originally developed for liposuction, involves infiltration of a dilute solution containing local anesthetic, vasoconstrictor, and adjunct agents to produce tissue tumescence. This technique enhances hemostasis, prolongs anesthesia, and may reduce inflammatory sequelae. While tumescent anesthesia has been explored in plastic, dermatologic, and orthognathic surgery, its role in impacted mandibular third molar surgery remains inadequately studied.
Therefore, this study was designed to evaluate the efficacy of tumescent steroid infiltration as an adjunct to conventional local anesthesia in reducing postoperative pain, swelling, and trismus following mandibular third molar surgery.
Study Objectives Primary Objective
To evaluate postoperative pain severity following surgical removal of impacted mandibular third molars using:
2% lidocaine with adrenaline alone versus 2% lidocaine with adrenaline combined with tumescent steroid infiltration
Secondary Objectives
- To compare postoperative facial swelling between the two interventions.
- To compare postoperative trismus (maximum interincisal mouth opening).
Study Design
Type of Study: Prospective, randomized, double-blind, split-mouth controlled clinical trial
Study Setting: Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak, Haryana, India
Blinding: Double-blind (Patient and outcome assessor blinded)
In the split-mouth design, each patient served as their own control. One side was randomly assigned to receive conventional local anesthesia (control), and the contralateral side received local anesthesia with adjunctive tumescent steroid infiltration (test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumescent Steroid Infiltration with 2% Lidocaine and Adrenaline in Mandibular Third Molar | Experimental | Drug: Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline)Participants received 2% lidocaine with adrenaline (1:2,00,000) using standard nerve block techniques. In addition, a 15 ml tumescent steroid solution was infiltrated submucosally after local anesthesia administration, targeting the mucogingival junction on the buccal aspect and the loose distal submucosa adjacent to the third molar. The tumescent solution comprised normal saline, bupivacaine, dexamethasone (8 mg), hyaluronidase (1500 IU), and adrenaline (1:1000 dilution). Surgical removal was then performed using the same standardized technique as in the control arm. Postoperative medications and instructions were identical to the control arm. |
| Conventional 2% Lidocaine with Adrenaline in Mandibular Third Molar Surgery | Active comparator | Drug: 2% lignocaine with adr (1:2,00,000)Participants received 2% lidocaine with adrenaline (1:2,00,000) administered via standard inferior alveolar nerve block, lingual nerve block, and long buccal nerve infiltration. No adjunctive anti-inflammatory or tumescent infiltration was administered. Surgical removal of the impacted mandibular third molar was performed using a standardized technique (Ward's/Modified Ward's flap, bone guttering with surgical bur, tooth sectioning when required, irrigation, and suturing). Postoperative medications and instructions were identical to the test arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline)A 15 mL tumescent solution containing dexamethasone (8 mg), bupivacaine, adrenaline (1:1000 dilution), hyaluronidase (1500 IU), and normal saline was administered via submucosal infiltration after standard inferior alveolar nerve block using 2% lidocaine with adrenaline (1:2,00,000). The solution was injected at the mucogingival junction on the buccal aspect of the mandibular molars and into the loose distal submucosa adjacent to the impacted third molar prior to surgical extraction. The intervention aimed to reduce postoperative inflammatory sequelae including pain, swelling, and trismus. | Drug | Tumescent Steroid Infiltration with 2% Lidocaine and Adrenaline in Mandibular Third Molar |
| 2% lignocaine with adr (1:2,00,000)Standard inferior alveolar nerve block, lingual nerve block, and long buccal nerve infiltration were administered using 2% lidocaine with adrenaline (1:2,00,000). No adjunctive steroid or tumescent infiltration was used in this arm. Surgical removal of the impacted mandibular third molar was performed using a standardized technique including mucoperiosteal flap elevation, bone guttering, tooth sectioning when required, irrigation, and suturing. Postoperative medications and follow-up protocol were identical to the test group. | Drug | Conventional 2% Lidocaine with Adrenaline in Mandibular Third Molar Surgery |
Primary outcome
Postoperative Pain Severity Following Mandibular Third Molar Surgery
Time frame: Immediate postoperative period, Postoperative Day 1, Day 2, and Day 7
Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. Pain scores will be recorded at immediate postoperative period and on postoperative Day 1, Day 2, and Day 7. The primary endpoint will be the difference in mean VAS pain scores between the control (2% lidocaine with adrenaline alone) and test (2% lidocaine with adrenaline plus tumescent steroid infiltration) sites, with particular emphasis on postoperative Day 1, when peak inflammatory pain is expected.
1 secondary outcome
Postoperative Facial Swelling and Trismus Following Mandibular Third Molar Surgery
Time frame: Preoperative baseline, Postoperative Day 1, Day 2, and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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.
Dr Virendra Singh, MDS study director
PGIDS ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumescent Infiltration (dexamethasone, bupivacaine, adrenaline, hyaluronidase, saline) and 2% lignocaine with adr (1:2,00,000) in people with Impacted Third Molar and Impacted Third Molar Tooth, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Pain Severity Following Mandibular Third Molar Surgery (time frame: Immediate postoperative period, Postoperative Day 1, Day 2, and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.