Tooth ExtractionNCT04875650
Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars
A study testing Extraction of Mandibular Molar using Physics Forceps and Extraction of Mandibular Molar using Conventional Forceps in people with Tooth Extraction, run by Melaka Manipal Medical College at 1 site in Malaysia.
Trial summary
Our study compared two different forceps for extraction of mandibular molars, the conventional extraction forceps and the Physics forceps. We assesed the relative pain score, patient satisfaction, success of extraction, incidence of alveolar plate fracture and soft tissue healing; post extraction. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Extraction of Mandibular Molar using Physics Forceps and Extraction of Mandibular Molar using Conventional Forceps
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Dec 2020to 20 Apr 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 18-55 years
- Mandibular molar teeth indicated for extractions with gingival index 1.
Who cannot join
- Patients with uncontrolled systemic diseases, that compromise dental extraction
- Mandibular 3rd Molars
- Grade 2 and 3 mobile teeth
- Grossly decayed mandibular molars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Physics Forceps and Conventional Forceps in Extraction of Mandibular Molars: A Double-Blinded Randomized Controlled Trial
Our study compared two different forceps for extraction of mandibular molars, the conventional extraction forceps and the Physics forceps. We assesed the relative pain score, patient satisfaction, success of extraction, incidence of alveolar plate fracture and soft tissue healing; post extraction. Our results found statistical significance in comparison of both forceps under relative pain score, patient satisfaction and soft tissue healing post extraction.
Read the detailed description
Abstract
- INTRODUCTION/ BACKGROUND Tooth extractions are commonly done with conventional forceps. Recent advances like physics forceps help in atraumatic extractions by preserving the buccal plate, having less pain and better gingival healing. The buccal portion of the forceps is a plastic covered bumper which prevents reflection of buccal gingiva and buccal plate fracture. This is the first such comparison study to measure gingival healing in mandibular molar region with D2 bone quality.
- OBJECTIVE To compare the efficacy of Physics Forceps and Conventional Forceps in extraction of mandibular molars by randomly dividing the patients in two groups. The efficacy is determined by comparing the success of extraction, relative pain score, incidence of alveolar fracture, patient satisfaction and soft tissue healing on 3rd post-operative day.
- METHODOLOGY Patients who were indicated for extraction were included in the study. They were divided into two groups of 10 by double blinded randomization. Local Anesthesia was administered and the extraction was carried out using either Physics or Conventional forceps. Post extraction, the pain score was assessed using the VAS. Along with these, the gingival healing, success of extraction and alveolar plate fracture was assessed by the subject expert on the 3rd day post-operative day.
- Conditions
- Tooth Extraction
- Being tested
- Extraction of Mandibular Molar using Physics Forceps, Extraction of Mandibular Molar using Conventional Forceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction of Mandibular Molar using Physics ForcepsProcedure or surgery
Extraction of mandibular molars using physics forceps
Extraction of Mandibular Molar using Conventional ForcepsProcedure or surgery
Extraction of mandibular molars using conventional forceps
| Study group | Role | What they receive |
|---|---|---|
| Physics Forceps | Experimental | Not described Receives: Procedure: Extraction of Mandibular Molar using Physics Forceps |
| Conventional Forcep | Other | Not described Receives: Procedure: Extraction of Mandibular Molar using Conventional Forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Pain Score
Use of a Visual Analogue Scale with 0 meaning no pain and 100 meaning severe pain
Measured: Day 1
Soft Tissue Healing Post Extraction
Soft Tissue Healing Index by Landry et al.
Measured: Day 3
Patient Satisfaction
4 point likert scale where 1 is very dissatisfied and 4 is very satisfied
Measured: Day 1
Success of Extraction
1 is Failure, 2 is limited success with osteotomy, 3 is limited success with root fracture, 4 is limited success with apical fracture and 5 is complete success
Measured: Day 1
Incidence of Alveolar Bone Fracture
Fracture 1 and No fracture 0
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start2 Dec 2020
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melaka Manipal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Auric Bhattacharya, Melaka Manipal Medical College
- Investigators
- Auric Bhattacharya, BDS, MDS, FICOI, MFDS, RCPS, Principal investigator, Melaka Manipal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875650
- Sponsor's protocol ID
- MMMC/FOD/AR/B8/E C-2020 (01)
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 6 May 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 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physics Forceps and Conventional Forceps in Extraction of Mandibular Molars: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04875650
- Acronym / sponsor ID
- MMMC/FOD/AR/B8/E C-2020 (01)
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Melaka Manipal Medical CollegeUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 6 May 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.
Our study compared two different forceps for extraction of mandibular molars, the conventional extraction forceps and the Physics forceps. We assesed the relative pain score, patient satisfaction, success of extraction, incidence of alveolar plate fracture and soft tissue healing; post extraction. Our results found statistical significance in comparison of both forceps under relative pain score, patient satisfaction and soft tissue healing post extraction.
Detailed description
Abstract
- INTRODUCTION/ BACKGROUND Tooth extractions are commonly done with conventional forceps. Recent advances like physics forceps help in atraumatic extractions by preserving the buccal plate, having less pain and better gingival healing. The buccal portion of the forceps is a plastic covered bumper which prevents reflection of buccal gingiva and buccal plate fracture. This is the first such comparison study to measure gingival healing in mandibular molar region with D2 bone quality.
- OBJECTIVE To compare the efficacy of Physics Forceps and Conventional Forceps in extraction of mandibular molars by randomly dividing the patients in two groups. The efficacy is determined by comparing the success of extraction, relative pain score, incidence of alveolar fracture, patient satisfaction and soft tissue healing on 3rd post-operative day.
- METHODOLOGY Patients who were indicated for extraction were included in the study. They were divided into two groups of 10 by double blinded randomization. Local Anesthesia was administered and the extraction was carried out using either Physics or Conventional forceps. Post extraction, the pain score was assessed using the VAS. Along with these, the gingival healing, success of extraction and alveolar plate fracture was assessed by the subject expert on the 3rd day post-operative day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physics Forceps | Experimental | Procedure: Extraction of Mandibular Molar using Physics Forceps |
| Conventional Forcep | Other | Procedure: Extraction of Mandibular Molar using Conventional Forceps |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients between 18-55 years
- Mandibular molar teeth indicated for extractions with gingival index 1.
Key exclusion criteria (4 listed)
- Patients with uncontrolled systemic diseases, that compromise dental extraction
- Mandibular 3rd Molars
- Grade 2 and 3 mobile teeth
- Grossly decayed mandibular molars
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 Molar using Physics ForcepsExtraction of mandibular molars using physics forceps | Procedure or surgery | Physics Forceps |
| Extraction of Mandibular Molar using Conventional ForcepsExtraction of mandibular molars using conventional forceps | Procedure or surgery | Conventional Forcep |
Primary outcome
Relative Pain Score
Time frame: Day 1
Use of a Visual Analogue Scale with 0 meaning no pain and 100 meaning severe pain
Soft Tissue Healing Post Extraction
Time frame: Day 3
Soft Tissue Healing Index by Landry et al.
Patient Satisfaction
Time frame: Day 1
4 point likert scale where 1 is very dissatisfied and 4 is very satisfied
Success of Extraction
Time frame: Day 1
1 is Failure, 2 is limited success with osteotomy, 3 is limited success with root fracture, 4 is limited success with apical fracture and 5 is complete success
Incidence of Alveolar Bone Fracture
Time frame: Day 1
Fracture 1 and No fracture 0
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 6 May 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.
Auric Bhattacharya, BDS, MDS, FICOI, MFDS, RCPS 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 Extraction of Mandibular Molar using Physics Forceps and Extraction of Mandibular Molar using Conventional Forceps in people with Tooth Extraction, 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 2 inclusion and 4 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 6 May 2021. 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?
Relative Pain Score (time frame: Day 1). The study lists 5 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 6 May 2021.