SwellingNCT03492814
Comparing Different Suturing Techniques on the Post-operative Morbidity After Removal of Impacted Mandibular Third Molar
A study testing partial wound closure and total wound closure in people with Swelling and Trismus, run by Melaka Manipal Medical College at 1 site in Malaysia.
Trial summary
This study compares the effect of two types of suturing techniques in the postoperative swelling and mouth opening after surgical removal of impacted mandibular third molar. total wound closure will be performed in one group of participants while partial closure will be performed in the other group. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- What is being tested?
- partial wound closure and total wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Mar 2016to 10 Mar 2018
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients undergoing surgical removal of mesioangular impacted mandibular third molar.
- Healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II).
- patients who are not allergic to the drugs and local anesthetic agent used in the surgical protocol.
Who cannot join
- Patients having systemic conditions that might have an effect on the bone growth or periodontal healing.
- patients who are on antibiotics premedication or any drugs that might affect wound healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effect of Different Suture Techniques on the Post Operative Morbidity After Surgical Removal of Impacted Mandibular Third Molar- A Randomized Clinical Study
This study compares the effect of two types of suturing techniques in the postoperative swelling and mouth opening after surgical removal of impacted mandibular third molar. total wound closure will be performed in one group of participants while partial closure will be performed in the other group.
Read the detailed description
Third molar surgeries are mostly associated with pain, swelling and limited mouth opening, referred to as post-operative morbidity. Wound closure technique is an operative factor which is associated with reduced post-operative morbidity. In the total wound closure, the mucoperiosteum is hermetically sealed whereas in the partial wound closure, a window or opening is left to allow for secondary healing. This study therefore compares the effect of partial and total wound closure techniques after surgical extraction of impacted mandibular third molar teeth in reducing the swelling and limited mouth opening.
- Being tested
- partial wound closure, total wound closure
- Keywords
- impacted third molar, suturing, post-operative morbidity
- Medical subject headings
- Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial wound closureProcedure or surgery
3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.
total wound closureProcedure or surgery
5 interrupted sutures with 2 sutures closing the vertical releasing incision and 3 sutures distal to second molar leading to a complete hermetic closure of the wound.
| Study group | Role | What they receive |
|---|---|---|
| Partial wound closure | Experimental | 3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures. Receives: Procedure: partial wound closure |
| Total wound closure | Active comparator | 5 interrupted sutures with 2 sutures closing the vertical releasing incision and 3 sutures distal to second molar leading to a complete hermetic closure of the wound. Receives: Procedure: total wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Measurement of mouth opening
mouth opening is measure by measuring the maximum interincisal distance from the incisal edge of maxillary right central incisor to the incisal edge of the lower right central incisor using a vernier calliper in mm.
Measured: baseline( preoperative) and 3rd and 7th day postoperatively.
postoperative swelling
three line measurements were performed in cm using a measuring tape and mean was taken
Measured: baseline ( preoperative) and 3rd and 7th day postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start10 Mar 2016
- Primary completion10 Mar 2018
- Study completion10 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SwellingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melaka Manipal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Kalam Azad, Melaka Manipal Medical College
- Investigators
- Abdul Kalam Azad, MDS, Principal investigator, Melaka Manipal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492814
- Sponsor's protocol ID
- MMMC/FOD/AR/B4/E C-2016(24)
- Status last verified
- Apr 2018
- First submitted
- 1 Apr 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Different Suture Techniques on the Post Operative Morbidity After Surgical Removal of Impacted Mandibular Third Molar- A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03492814
- Acronym / sponsor ID
- MMMC/FOD/AR/B4/E C-2016(24)
- Keywords
- impacted third molar, suturing, post-operative morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Melaka Manipal Medical CollegeUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 10 Mar 2018 (actual)
- First posted
- 10 Apr 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.
This study compares the effect of two types of suturing techniques in the postoperative swelling and mouth opening after surgical removal of impacted mandibular third molar. total wound closure will be performed in one group of participants while partial closure will be performed in the other group.
Detailed description
Third molar surgeries are mostly associated with pain, swelling and limited mouth opening, referred to as post-operative morbidity. Wound closure technique is an operative factor which is associated with reduced post-operative morbidity. In the total wound closure, the mucoperiosteum is hermetically sealed whereas in the partial wound closure, a window or opening is left to allow for secondary healing. This study therefore compares the effect of partial and total wound closure techniques after surgical extraction of impacted mandibular third molar teeth in reducing the swelling and limited mouth opening.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial wound closure | Experimental | Procedure: partial wound closure3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures. |
| Total wound closure | Active comparator | Procedure: total wound closure5 interrupted sutures with 2 sutures closing the vertical releasing incision and 3 sutures distal to second molar leading to a complete hermetic closure of the wound. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patients undergoing surgical removal of mesioangular impacted mandibular third molar.
- Healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II).
- patients who are not allergic to the drugs and local anesthetic agent used in the surgical protocol.
Key exclusion criteria (2 listed)
- Patients having systemic conditions that might have an effect on the bone growth or periodontal healing.
- patients who are on antibiotics premedication or any drugs that might affect wound healing.
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 |
|---|---|---|
| partial wound closure3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures. | Procedure or surgery | Partial wound closure |
| total wound closure5 interrupted sutures with 2 sutures closing the vertical releasing incision and 3 sutures distal to second molar leading to a complete hermetic closure of the wound. | Procedure or surgery | Total wound closure |
Primary outcome
change in the Measurement of mouth opening
Time frame: baseline( preoperative) and 3rd and 7th day postoperatively.
mouth opening is measure by measuring the maximum interincisal distance from the incisal edge of maxillary right central incisor to the incisal edge of the lower right central incisor using a vernier calliper in mm.
postoperative swelling
Time frame: baseline ( preoperative) and 3rd and 7th day postoperatively.
three line measurements were performed in cm using a measuring tape and mean was taken
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 10 Apr 2018.
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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.
Abdul Kalam Azad, MDS principal investigator
Melaka Manipal Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial wound closure and total wound closure in people with Swelling and Trismus, run by Melaka Manipal Medical College at 1 site in Malaysia.
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 2 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: finished, as of the sponsor's last update on 10 Apr 2018. 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 Malaysia. 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?
change in the Measurement of mouth opening (time frame: baseline( preoperative) and 3rd and 7th day postoperatively.). 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?
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 10 Apr 2018.