Pain, PostoperativeNCT05032989
Extraction of Distoangular and Vertically Positioned Mandibular 3rd Molars
A study testing Extraction of mandibular 3rd molar via Cowhorn forcep technique and Extraction of mandibular 3rd molar via conventional technique in people with Pain, Postoperative, run by Dow University of Health Sciences.
Trial summary
Mandibular 3rd molars are the most commonly impacted teeth in oral cavity followed by maxillary 3rd molars and maxillary canines respectively. Impaction is a condition where a tooth fails to erupt in its final functional position, theoretically owing to inadequate space distal to the second mandibular molar and the… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Extraction of mandibular 3rd molar via Cowhorn forcep technique and Extraction of mandibular 3rd molar via conventional technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2021to Jun 2022
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with bilateral distoangular and vertically positioned 3rd mandibular molars requiring extractions
- Bilateral partially impacted or erupted mandibular 3rd molars
- Both male and female patients
- Teeth which can be extracted by Intra-alveolar method under local anaesthesia
- Ages 18-35years
Who cannot join
- Patients refusing to sign the informed consent
- Patients that are medically compromised (systemic diseases)
- Teeth having radiographically evident large periapical changes (abscess/granuloma/cyst)
- Patients previously treated with radiotherapy or chemotherapy or both
- Carious mandibular 2nd molar or missing 1st molar
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Extraction of Distoangular and Vertically Positioned Mandibular 3rd Molars, A Comparative Study: Conventional Surgical Technique vs. Cowhorn Forceps Technique
Mandibular 3rd molars are the most commonly impacted teeth in oral cavity followed by maxillary 3rd molars and maxillary canines respectively. Impaction is a condition where a tooth fails to erupt in its final functional position, theoretically owing to inadequate space distal to the second mandibular molar and the anterior border of the ascending ramus of the mandible . Surgical removal of the third molar is the most common procedure carried out by a maxillofacial surgeon in the dental office. Surgical extractions are time consuming, expensive and cause morbidities such as pain, swelling, dry socket, trismus, and nerve injury when compared to non-surgical extractions. Various classifications have been proposed for mandibular 3rd molars, most common of which, is based on angulation of impacted tooth to the long axis of 2nd molar. Distoangular impacted 3rd molars are very difficult to remove because of lack of space distal to the tooth and lack of interdental space available for the application of elevator. Cowhorn forcep engages between the bifurcation of the mandibular molars and below the bone crest and causes displacement of tooth by upward movement or by splitting mesial and distal root. In our study cowhorn forcep are fist placed between 2nd and 3rd molar below the cementoenamel junction after its placement an apical pressure in applied and this rotation results an upward and distal movement and displacement of impacted tooth from the socket which then can easily be removed with cow horn forcep or molar crown forcep. The aim of our study is to present the minimal invasive technique for the extraction of distoangular and vertical impacted mandibular 3rd molars using cow horn forcep in comparison to conventional surgical techniques to avoid complications associated with open surgical techniques .
METHOD:
Total 128 patients will be recruited and divided into 64 patients in each group (two groups) attending in Dr. inshrat ul ebad institute of oral health sciences, Ojha, fulfilling inclusion criteria and undergoing extraction of 3rd molars will be included in this study. The participant will be briefed about the nature and purpose of the study. They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from the patients will be taken and pre-operative evaluation will be done by clinical (pain and swelling) and radiographical (angulation of the tooth) examination. All the patients would undergo extraction of 3rd molars via both either conventional surgical technique or the proposed technique in the study. Followup will be done after 3 days to evaluate the same post-operative variables (pain and swelling) after extraction of 3rd molar and both techniques will then be compared in terms of variables measured.
Read the detailed description
Mandibular 3rd molars are the most commonly impacted teeth in oral cavity followed by maxillary 3rd molars and maxillary canines respectively. Impaction is a condition where a tooth fails to erupt in its final functional position, theoretically owing to inadequate space distal to the second mandibular molar and the anterior border of the ascending ramus of the mandible . Surgical removal of the third molar is the most common procedure carried out by a maxillofacial surgeon in the dental office. Surgical extractions are time consuming, expensive and cause morbidities such as pain, swelling, dry socket, trismus, and nerve injury when compared to non-surgical extractions. Various classifications have been proposed for mandibular 3rd molars, most common of which, is based on angulation of impacted tooth to the long axis of 2nd molar. Distoangular impacted 3rd molars are very difficult to remove because of lack of space distal to the tooth and lack of interdental space available for the application of elevator. Cowhorn forcep engages between the bifurcation of the mandibular molars and below the bone crest and causes displacement of tooth by upward movement or by splitting mesial and distal root. In our study cowhorn forcep are fist placed between 2nd and 3rd molar below the cementoenamel junction after its placement an apical pressure in applied and this rotation results an upward and distal movement and displacement of impacted tooth from the socket which then can easily be removed with cow horn forcep or molar crown forcep.The aim of our study is to present the minimal invasive technique for the extraction of distoangular and vertical impacted mandibular 3rd molars using cow horn forcep in comparison to conventional surgical techniques to avoid complications associated with open surgical techniques .
Objective:
To compare the effectiveness of new technique using cow horn forcep with conventional surgical method among patients with vertical and distoangular lower third molar impactions requiring extraction.
Method:
Total 128 patients will be recruited and divided into 64 patients in each group (two groups) attending in Dr. inshrat ul ebad institute of oral health sciences, Ojha, fulfilling inclusion criteria and undergoing extraction of 3rd molars will be included in this study. The participant will be briefed about the nature and purpose of the study. They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from the patients will be taken and pre-operative evaluation will be done by clinical (pain and swelling) and radiographical (angulation of the tooth) examination. All the patients would undergo extraction of 3rd molars via both either conventional surgical technique or the proposed technique in the study. Followup will be done after 3 days to evaluate the same post-operative variables (pain and swelling) after extraction of 3rd molar and both techniques will then be compared in terms of variables measured.
- Conditions
- Pain, Postoperative
- Being tested
- Extraction of mandibular 3rd molar via Cowhorn forcep technique, Extraction of mandibular 3rd molar via conventional technique
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction of mandibular 3rd molar via Cowhorn forcep techniqueProcedure or surgery
Cowhorn forceps technique used to extract the tooth results in less post operative pain and swelling also it makes the extraction easier.
Extraction of mandibular 3rd molar via conventional techniqueProcedure or surgery
Conventional method of extraction uses dental elevator and forceps resulting in post operative pain and swellig.
| Study group | Role | What they receive |
|---|---|---|
| Extraction of distoangular and vertically positioned 3rd molar using cowhorn forcep | Experimental | Extraction with new technique Receives: Procedure: Extraction of mandibular 3rd molar via Cowhorn forcep technique |
| Extraction of distoangular and vertically positioned 3rd molar via conventional method | Active comparator | Extraction with the conventional technique Receives: Procedure: Extraction of mandibular 3rd molar via conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease post operative pain and swelling
cownhorn forcep technique is used to reduce post operative pain and swelling
Measured: 3rd post operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start15 Sep 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Wajid Hasan, Dow University of Health Sciences
- Investigators
- Syed Wajid Hasan, BDS, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032989
- Sponsor's protocol ID
- wajid001
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraction of Distoangular and Vertically Positioned Mandibular 3rd Molars, A Comparative Study: Conventional Surgical Technique vs. Cowhorn Forceps Technique
- ClinicalTrials.gov ID
- NCT05032989
- Acronym / sponsor ID
- wajid001
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 2 Sep 2021 (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.
Mandibular 3rd molars are the most commonly impacted teeth in oral cavity followed by maxillary 3rd molars and maxillary canines respectively. Impaction is a condition where a tooth fails to erupt in its final functional position, theoretically owing to inadequate space distal to the second mandibular molar and the anterior border of the ascending ramus of the mandible . Surgical removal of the third molar is the most common procedure carried out by a maxillofacial surgeon in the dental office. Surgical extractions are time consuming, expensive and cause morbidities such as pain, swelling, dry socket, trismus, and nerve injury when compared to non-surgical extractions. Various classifications have been proposed for mandibular 3rd molars, most common of which, is based on angulation of impacted tooth to the long axis of 2nd molar. Distoangular impacted 3rd molars are very difficult to remove because of lack of space distal to the tooth and lack of interdental space available for the application of elevator. Cowhorn forcep engages between the bifurcation of the mandibular molars and below the bone crest and causes displacement of tooth by upward movement or by splitting mesial and distal root. In our study cowhorn forcep are fist placed between 2nd and 3rd molar below the cementoenamel junction after its placement an apical pressure in applied and this rotation results an upward and distal movement and displacement of impacted tooth from the socket which then can easily be removed with cow horn forcep or molar crown forcep. The aim of our study is to present the minimal invasive technique for the extraction of distoangular and vertical impacted mandibular 3rd molars using cow horn forcep in comparison to conventional surgical techniques to avoid complications associated with open surgical techniques .
METHOD:
Total 128 patients will be recruited and divided into 64 patients in each group (two groups) attending in Dr. inshrat ul ebad institute of oral health sciences, Ojha, fulfilling inclusion criteria and undergoing extraction of 3rd molars will be included in this study. The participant will be briefed about the nature and purpose of the study. They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from the patients will be taken and pre-operative evaluation will be done by clinical (pain and swelling) and radiographical (angulation of the tooth) examination. All the patients would undergo extraction of 3rd molars via both either conventional surgical technique or the proposed technique in the study. Followup will be done after 3 days to evaluate the same post-operative variables (pain and swelling) after extraction of 3rd molar and both techniques will then be compared in terms of variables measured.
Detailed description
Mandibular 3rd molars are the most commonly impacted teeth in oral cavity followed by maxillary 3rd molars and maxillary canines respectively. Impaction is a condition where a tooth fails to erupt in its final functional position, theoretically owing to inadequate space distal to the second mandibular molar and the anterior border of the ascending ramus of the mandible . Surgical removal of the third molar is the most common procedure carried out by a maxillofacial surgeon in the dental office. Surgical extractions are time consuming, expensive and cause morbidities such as pain, swelling, dry socket, trismus, and nerve injury when compared to non-surgical extractions. Various classifications have been proposed for mandibular 3rd molars, most common of which, is based on angulation of impacted tooth to the long axis of 2nd molar. Distoangular impacted 3rd molars are very difficult to remove because of lack of space distal to the tooth and lack of interdental space available for the application of elevator. Cowhorn forcep engages between the bifurcation of the mandibular molars and below the bone crest and causes displacement of tooth by upward movement or by splitting mesial and distal root. In our study cowhorn forcep are fist placed between 2nd and 3rd molar below the cementoenamel junction after its placement an apical pressure in applied and this rotation results an upward and distal movement and displacement of impacted tooth from the socket which then can easily be removed with cow horn forcep or molar crown forcep.The aim of our study is to present the minimal invasive technique for the extraction of distoangular and vertical impacted mandibular 3rd molars using cow horn forcep in comparison to conventional surgical techniques to avoid complications associated with open surgical techniques .
Objective:
To compare the effectiveness of new technique using cow horn forcep with conventional surgical method among patients with vertical and distoangular lower third molar impactions requiring extraction.
Method:
Total 128 patients will be recruited and divided into 64 patients in each group (two groups) attending in Dr. inshrat ul ebad institute of oral health sciences, Ojha, fulfilling inclusion criteria and undergoing extraction of 3rd molars will be included in this study. The participant will be briefed about the nature and purpose of the study. They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from the patients will be taken and pre-operative evaluation will be done by clinical (pain and swelling) and radiographical (angulation of the tooth) examination. All the patients would undergo extraction of 3rd molars via both either conventional surgical technique or the proposed technique in the study. Followup will be done after 3 days to evaluate the same post-operative variables (pain and swelling) after extraction of 3rd molar and both techniques will then be compared in terms of variables measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extraction of distoangular and vertically positioned 3rd molar using cowhorn forcep | Experimental | Procedure: Extraction of mandibular 3rd molar via Cowhorn forcep techniqueExtraction with new technique |
| Extraction of distoangular and vertically positioned 3rd molar via conventional method | Active comparator | Procedure: Extraction of mandibular 3rd molar via conventional techniqueExtraction with the conventional technique |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with bilateral distoangular and vertically positioned 3rd mandibular molars requiring extractions
- Bilateral partially impacted or erupted mandibular 3rd molars
- Both male and female patients
- Teeth which can be extracted by Intra-alveolar method under local anaesthesia
- Ages 18-35years
Key exclusion criteria (5 listed)
- Patients refusing to sign the informed consent
- Patients that are medically compromised (systemic diseases)
- Teeth having radiographically evident large periapical changes (abscess/granuloma/cyst)
- Patients previously treated with radiotherapy or chemotherapy or both
- Carious mandibular 2nd molar or missing 1st molar
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 |
|---|---|---|
| Extraction of mandibular 3rd molar via Cowhorn forcep techniqueCowhorn forceps technique used to extract the tooth results in less post operative pain and swelling also it makes the extraction easier. | Procedure or surgery | Extraction of distoangular and vertically positioned 3rd molar using cowhorn forcep |
| Extraction of mandibular 3rd molar via conventional techniqueConventional method of extraction uses dental elevator and forceps resulting in post operative pain and swellig. | Procedure or surgery | Extraction of distoangular and vertically positioned 3rd molar via conventional method |
Primary outcome
Decrease post operative pain and swelling
Time frame: 3rd post operative day
cownhorn forcep technique is used to reduce post operative pain and swelling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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.
Syed Wajid Hasan, BDS principal investigator
DUHS
Questions about this trial
What is this clinical trial studying?
A study testing Extraction of mandibular 3rd molar via Cowhorn forcep technique and Extraction of mandibular 3rd molar via conventional technique in people with Pain, Postoperative, run by Dow University 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 5 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 2 Sep 2021. 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.
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 Syed Wajid Hasan, BDS (03351350139, syedwajidhasan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease post operative pain and swelling (time frame: 3rd post operative day). 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 2 Sep 2021.