Regenerative Periodontal TreatmentNCT03145246
Long-Term Outcome Following Regenerative Periodontal Treatment of Intrabony Defects
An observational study of Regenerative Periodontal Treatment, run by Mahidol University.
Trial summary
Many years ago, periodontal regenerative treatment has been done in Periodontics and Oral Medicine Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. However, there is still lacking of study about long-term result of periodontal regenerative treatment of intrabony defects. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Regenerative Periodontal Treatment
- What is being tested?
- regeneration treated teeth loss and regenerated treated teeth with clinical attachment loss
- Type of treatment
- Surgery or procedure
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2015
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The patients who received regenerative periodontal therapy of the intrabony defects by post-graduate students at the Periodontics and Oral Medicine Clinic, Faculty of Dentistry, Mahidol University, Thailand and were placed in the Recall Patient Bank from 2000 to 2014.
Who may be able to join
- Patients who received regenerative therapy of the intrabony defects
- Patients who had the record of re-evaluation at 1 year post-surgery
Who cannot join
- Patients who received regenerative therapy involving the furcation area
- Patients who received non-periodontal regenerative therapy
- Patients who received endodontic regeneration
- Patients who had an incomplete periodontal data recording
About this study
Official title: Long-Term Outcome Following Regenerative Periodontal Treatment of Intrabony Defects: A Retrospective Study at Mahidol University
Many years ago, periodontal regenerative treatment has been done in Periodontics and Oral Medicine Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. However, there is still lacking of study about long-term result of periodontal regenerative treatment of intrabony defects.
Read the detailed description
Beside, in the present, some materials for periodontal regenerative treatment are still expensive. Periodontists and patients have to plan together based on not only rationale of treatment but also cost and effectiveness. Thus the long-term result of treatment could be useful for the decision making.
- Conditions
- Regenerative Periodontal Treatment
- Being tested
- regeneration treated teeth loss, regenerated treated teeth with clinical attachment loss
- Keywords
- intrabony defect, periodontal regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regeneration treated teeth lossProcedure or surgery
number of regeneration treated teeth loss
regenerated treated teeth with clinical attachment lossProcedure or surgery
regenerated treated teeth with clinical attachment loss ≥ 2 mm
| Study group | Role | What they receive |
|---|---|---|
| tooth loss | regeneration treated teeth loss Receives: Procedure: regeneration treated teeth loss | |
| clinical attachment loss ≥ 2 mm | regenerated treated teeth with clinical attachment loss ≥ 2 mm Receives: Procedure: regenerated treated teeth with clinical attachment loss | |
| clinical attachment loss loss < 2 mm | regenerated treated teeth with clinical attachment loss < 2 mm Receives: Procedure: regenerated treated teeth with clinical attachment loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of regenerative-treated tooth loss after periodontal regeneration
Percentage of regenerative-treated tooth loss since 1 year after periodontal regeneration until last visit of supportive periodontal treatment
Measured: 1 year
Percentage of regenerative-treated sites with clinical attachment loss ≥ 2 mm
Percentage of regenerative-treated sites with clinical attachment loss ≥ 2 mm since 1 year after periodontal regeneration until last visit of supportive periodontal treatment
Measured: 1 year
Secondary outcomes (1)
Variables (patient and tooth characteristics) that associated with tooth loss or clinical attachment loss
Patient variables and tooth characteristics associated with regenerative-treated tooth loss or sites with clinical attachment loss ≥ 2 mm from any supportive periodontal treatment visits (the last supportive periodontal treatment visit) compared to baseline or 1-year after surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative Periodontal TreatmentStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanyawat Rattanasuwan, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145246
- Sponsor's protocol ID
- 2014/DT105
- Status last verified
- May 2017
- First submitted
- 13 Nov 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcome Following Regenerative Periodontal Treatment of Intrabony Defects: A Retrospective Study at Mahidol University
- ClinicalTrials.gov ID
- NCT03145246
- Acronym / sponsor ID
- 2014/DT105
- Conditions
- Regenerative Periodontal Treatment
- Keywords
- intrabony defect, periodontal regeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 May 2017 (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.
Many years ago, periodontal regenerative treatment has been done in Periodontics and Oral Medicine Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. However, there is still lacking of study about long-term result of periodontal regenerative treatment of intrabony defects.
Detailed description
Beside, in the present, some materials for periodontal regenerative treatment are still expensive. Periodontists and patients have to plan together based on not only rationale of treatment but also cost and effectiveness. Thus the long-term result of treatment could be useful for the decision making.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tooth loss | – | Procedure: regeneration treated teeth lossregeneration treated teeth loss |
| clinical attachment loss ≥ 2 mm | – | Procedure: regenerated treated teeth with clinical attachment lossregenerated treated teeth with clinical attachment loss ≥ 2 mm |
| clinical attachment loss loss < 2 mm | – | Procedure: regenerated treated teeth with clinical attachment lossregenerated treated teeth with clinical attachment loss < 2 mm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who received regenerative periodontal therapy of the intrabony defects by post-graduate students at the Periodontics and Oral Medicine Clinic, Faculty of Dentistry, Mahidol University, Thailand and were placed in the Recall Patient Bank from 2000 to 2014.
Key inclusion criteria (2 listed)
- Patients who received regenerative therapy of the intrabony defects
- Patients who had the record of re-evaluation at 1 year post-surgery
Key exclusion criteria (4 listed)
- Patients who received regenerative therapy involving the furcation area
- Patients who received non-periodontal regenerative therapy
- Patients who received endodontic regeneration
- Patients who had an incomplete periodontal data recording
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 |
|---|---|---|
| regeneration treated teeth lossnumber of regeneration treated teeth loss | Procedure or surgery | tooth loss |
| regenerated treated teeth with clinical attachment lossregenerated treated teeth with clinical attachment loss ≥ 2 mm | Procedure or surgery | clinical attachment loss loss < 2 mm, clinical attachment loss ≥ 2 mm |
Primary outcome
Percentage of regenerative-treated tooth loss after periodontal regeneration
Time frame: 1 year
Percentage of regenerative-treated tooth loss since 1 year after periodontal regeneration until last visit of supportive periodontal treatment
Percentage of regenerative-treated sites with clinical attachment loss ≥ 2 mm
Time frame: 1 year
Percentage of regenerative-treated sites with clinical attachment loss ≥ 2 mm since 1 year after periodontal regeneration until last visit of supportive periodontal treatment
1 secondary outcome
Variables (patient and tooth characteristics) that associated with tooth loss or clinical attachment loss
Time frame: 1 year
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 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Kanyawat Rattanasuwan study director
Mahidol University
Questions about this trial
What is this clinical trial studying?
An observational study of Regenerative Periodontal Treatment, run by Mahidol University.
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 9 May 2017. 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?
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?
Percentage of regenerative-treated tooth loss after periodontal regeneration (time frame: 1 year). 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 9 May 2017.