Periodontal PocketNCT06073639
The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction
A study testing Autogenous dentin graft in people with Periodontal Pocket and Swelling Lips & Face, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The study aimed to investigate clinical effect of autogenous dentin graft on patients following mandibular wisdom tooth extraction. The primary outcomes are pain, swelling, trismus and soft tissue healing index within one week after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket, Swelling Lips & Face, Trismus
- What is being tested?
- Autogenous dentin graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2021to 28 Feb 2024
- 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
Who may be able to join
- Over 18 years old
- Symmetry mandibular third molars
- Symmetry maxillary third molars with no caries or periodontal disease
- Mandibular second molars are available
Who cannot join
- Systematic health has contraindication for surgery
- Pregnant or breastfeeding women
- Allergy with Lidocaine
- Abnormal signs surrounding mandibular third molars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Effect of Autogenous Dentin Graft in Mandibular Third Molar Surgery
The study aimed to investigate clinical effect of autogenous dentin graft on patients following mandibular wisdom tooth extraction. The primary outcomes are pain, swelling, trismus and soft tissue healing index within one week after surgery. The investigators also measured periodontal healing of distal aspect of the adjacent second molar up to 2 year after the surgery.
- Conditions
- Periodontal Pocket, Swelling Lips & Face, Trismus, Pain, Acute
- Being tested
- Autogenous dentin graft
- Medical subject headings
- Periodontal Pocket, Facies, Trismus, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous dentin graftProcedure or surgery
Dentin graft is made from the participant extracted tooth by using Kometa Smart Dentin Grinder
| Study group | Role | What they receive |
|---|---|---|
| Dentin graft | Experimental | Not described Receives: Procedure: Autogenous dentin graft |
| Conventional | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of self-reported pain
Pain is measured by self-reported Likert scale from 0 to 5. Higher score indicated more painful situation. Result is reported by the mean score.
Measured: 3 days, 7 days
Self-reported swelling
Patients reported their perception about swelling levels. There are 6 levels of this scale, score from 0 to 5. Higher score means more swelling.
Measured: 3 days, 7 days
Trismus
Trismus is measured by difference of maximal mouth opening between post-and pre-operative wisdom tooth surgery. Maximal mouth opening is mueasured by distance of mesial incisal edge of maxillary and mandibular central incisor.
Measured: 3 days, 7 days
Soft tissue healing score
The soft tissue healing score is evaluated according to Hamzami (2018). It includes 8 sub-items. Each item is recorded as 0 or 1 (score). Then, total score of the first 30 days (3 evaluation time) is used to classify wound healing level (good, acceptable, and bad).
Measured: 3 days, 7 days, 30 days
Aveolar height
Aveolar height is measured as the distance from cementoenamel joint on distal surface of second molar to the aveolar ridge. The landmark points are defined on periapical film. The aveolar height is measured at 7 days, 3 months, 6 months and 2 years after the surgery.
Measured: 7 days, 2 months, 6 months, 2 years
Swelling measured by facial dimension
Difference of distances of facial landmark points between post-and pre-operative wisdom tooth surgery. Two distances (AB and CD) from 4 landmark points are used for measurement: A - lateral commissure of the eye, B - gonion, C - tragus, and D - lateral commissure of the lips.
Measured: 3 days, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Dec 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Son Hoang Le, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Son H Le, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073639
- Sponsor's protocol ID
- VN01002/IORG00086/FWA0002448
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Autogenous Dentin Graft in Mandibular Third Molar Surgery
- ClinicalTrials.gov ID
- NCT06073639
- Acronym / sponsor ID
- VN01002/IORG00086/FWA0002448
- Conditions
- Periodontal Pocket, Swelling Lips & Face, Trismus, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 10 Oct 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 study aimed to investigate clinical effect of autogenous dentin graft on patients following mandibular wisdom tooth extraction. The primary outcomes are pain, swelling, trismus and soft tissue healing index within one week after surgery. The investigators also measured periodontal healing of distal aspect of the adjacent second molar up to 2 year after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dentin graft | Experimental | Procedure: Autogenous dentin graft |
| Conventional | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Symmetry mandibular third molars
- Symmetry maxillary third molars with no caries or periodontal disease
- Mandibular second molars are available
Key exclusion criteria (4 listed)
- Systematic health has contraindication for surgery
- Pregnant or breastfeeding women
- Allergy with Lidocaine
- Abnormal signs surrounding mandibular third 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 |
|---|---|---|
| Autogenous dentin graftDentin graft is made from the participant extracted tooth by using Kometa Smart Dentin Grinder | Procedure or surgery | Dentin graft |
Primary outcome
Rate of self-reported pain
Time frame: 3 days, 7 days
Pain is measured by self-reported Likert scale from 0 to 5. Higher score indicated more painful situation. Result is reported by the mean score.
Self-reported swelling
Time frame: 3 days, 7 days
Patients reported their perception about swelling levels. There are 6 levels of this scale, score from 0 to 5. Higher score means more swelling.
Trismus
Time frame: 3 days, 7 days
Trismus is measured by difference of maximal mouth opening between post-and pre-operative wisdom tooth surgery. Maximal mouth opening is mueasured by distance of mesial incisal edge of maxillary and mandibular central incisor.
Soft tissue healing score
Time frame: 3 days, 7 days, 30 days
The soft tissue healing score is evaluated according to Hamzami (2018). It includes 8 sub-items. Each item is recorded as 0 or 1 (score). Then, total score of the first 30 days (3 evaluation time) is used to classify wound healing level (good, acceptable, and bad).
Aveolar height
Time frame: 7 days, 2 months, 6 months, 2 years
Aveolar height is measured as the distance from cementoenamel joint on distal surface of second molar to the aveolar ridge. The landmark points are defined on periapical film. The aveolar height is measured at 7 days, 3 months, 6 months and 2 years after the surgery.
Swelling measured by facial dimension
Time frame: 3 days, 7 days
Difference of distances of facial landmark points between post-and pre-operative wisdom tooth surgery. Two distances (AB and CD) from 4 landmark points are used for measurement: A - lateral commissure of the eye, B - gonion, C - tragus, and D - lateral commissure of the lips.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Yes
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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.
Son H Le principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous dentin graft in people with Periodontal Pocket and Swelling Lips & Face, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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 Vietnam. 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?
Results are not available in the source record.
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?
Rate of self-reported pain (time frame: 3 days, 7 days). The study lists 6 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 Oct 2023.