Aggressive Periodontitis, GeneralizedNCT03090282
Subgingival Microbiota Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Periodontitis Patients
An observational study of Aggressive Periodontitis, Generalized, run by Peking University at 1 site in China.
Trial summary
The investigators planed to observe the microbiome of an aggressive periodontitis patient, during mechanical treatment, surgery(if indicated) and implant placement. The investigators designed to observe the changes after mechanical treatment.Then, the investigators will compare the sub-mucosa microbiome of implant and… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Aggressive Periodontitis, Generalized
- What is being tested?
- mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2016to 1 Mar 2022
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: aggressive periodontitis patients with defection of dentition or shall extracted hopeless teeth, and intended to implant treatment.
Who may be able to join
- Subjects were between 18-35 years old and diagnosed with generalized aggressive periodontitis (GAgP) according to the 1999 International Classification of Periodontal Diseases (Armitage 1999);
- At least 20 teeth in the first appointment and at least 3 teeth(other than first molars and central incisors)with a probing depth(PD) ≥ 6mm, clinical attachment level (CAL)≥5mm;
- The clinical diagnosis was confirmed by evidence of inter-proximal bone loss on full-mouth periapical radiographs;
- Family history of aggressive periodontitis.
Who cannot join
- Uncontrolled systemic conditions including diabetes and hypertension;
- Pregnant or lactating;
- Smoking;
- Received periodontal treatment within the previous 6 months or antibiotic medication during the previous 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university hospital of stomatology
Beijing, Beijing Municipality, 100081
About this study
Official title: Subgingival Microbiome Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Aggressive Periodontitis Patients
The investigators planed to observe the microbiome of an aggressive periodontitis patient, during mechanical treatment, surgery(if indicated) and implant placement. The investigators designed to observe the changes after mechanical treatment.Then, the investigators will compare the sub-mucosa microbiome of implant and the subgingival community. The investigators expected a different community after treatment, and there could be similarity between implant and nature teeth.
- Conditions
- Aggressive Periodontitis, Generalized
- Being tested
- mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.
- Keywords
- mechanical treatment, implant
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.Procedure or surgery
The investigators shall follow the regular procedure to these patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)
the diversity of subgingival community before and after mechanical treatment
Measured: Baseline, 6 weeks after mechanical treatment
changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)
the diversity of submucosa community before and after implatation
Measured: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
changes of prevalence and abundance of OTUs
compute and compare the prevalence and abundance of OTUs
Measured: Baseline, 6 weeks after mechanical treatment
changes of prevalence and abundance of OTUs
compute and compare the prevalence and abundance of OTUs
Measured: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
Secondary outcomes (3)
changes of bleeding index
bleeding index after probing
Measured: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
changes of probing depth
probing depth of indicated sites
Measured: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
clinical attachment loss
by probe, the distance between CEJ and gingival sulcus
Measured: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Apr 2016
- Primary completion1 Dec 2020
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aggressive Periodontitis, GeneralizedStudies of the same condition, open and under way.
- More trials run by Peking 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu guojing, Peking University
- Investigators
- Yu xiaoqian, Study chair, Peking University Hospital of StomatologyLiu guojing, Principal investigator, Peking University Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090282
- Sponsor's protocol ID
- PKUSSIRB-201525102
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2017
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: haven't decided yet
Publications
Liu G, Luan Q, Chen F, Chen Z, Zhang Q, Yu X. Shift in the subgingival microbiome following scaling and root planing in generalized aggressive periodontitis. J Clin Periodontol. 2018 Apr;45(4):440-452. doi: 10.1111/jcpe.12862. Epub 2018 Mar 6.
PubMed 29266363
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subgingival Microbiome Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Aggressive Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03090282
- Acronym / sponsor ID
- PKUSSIRB-201525102
- Conditions
- Aggressive Periodontitis, Generalized
- Keywords
- mechanical treatment, implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 24 Mar 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.
The investigators planed to observe the microbiome of an aggressive periodontitis patient, during mechanical treatment, surgery(if indicated) and implant placement. The investigators designed to observe the changes after mechanical treatment.Then, the investigators will compare the sub-mucosa microbiome of implant and the subgingival community. The investigators expected a different community after treatment, and there could be similarity between implant and nature teeth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- aggressive periodontitis patients with defection of dentition or shall extracted hopeless teeth, and intended to implant treatment.
Key inclusion criteria (4 listed)
- Subjects were between 18-35 years old and diagnosed with generalized aggressive periodontitis (GAgP) according to the 1999 International Classification of Periodontal Diseases (Armitage 1999);
- At least 20 teeth in the first appointment and at least 3 teeth(other than first molars and central incisors)with a probing depth(PD) ≥ 6mm, clinical attachment level (CAL)≥5mm;
- The clinical diagnosis was confirmed by evidence of inter-proximal bone loss on full-mouth periapical radiographs;
- Family history of aggressive periodontitis.
Key exclusion criteria (4 listed)
- Uncontrolled systemic conditions including diabetes and hypertension;
- Pregnant or lactating;
- Smoking;
- Received periodontal treatment within the previous 6 months or antibiotic medication during the previous 3 months.
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 |
|---|---|---|
| mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.The investigators shall follow the regular procedure to these patients. | Procedure or surgery | – |
Primary outcome
changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)
Time frame: Baseline, 6 weeks after mechanical treatment
the diversity of subgingival community before and after mechanical treatment
changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)
Time frame: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
the diversity of submucosa community before and after implatation
changes of prevalence and abundance of OTUs
Time frame: Baseline, 6 weeks after mechanical treatment
compute and compare the prevalence and abundance of OTUs
changes of prevalence and abundance of OTUs
Time frame: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.
compute and compare the prevalence and abundance of OTUs
3 secondary outcomes
changes of bleeding index
Time frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
changes of probing depth
Time frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
clinical attachment loss
Time frame: Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.
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 29 Mar 2023.
- Derived from this study: PubMed 29266363Liu G, Luan Q, Chen F, Chen Z, Zhang Q, Yu X. Shift in the subgingival microbiome following scaling and root planing in generalized aggressive periodontitis. J Clin Periodontol. 2018 Apr;45(4):440-452. doi: 10.1111/jcpe.12862. Epub 2018 Mar 6.
- Individual participant dataSharing planned: Undecided. haven't decided yet
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.
Yu xiaoqian study chair
Peking University Hospital of Stomatology
Liu guojing principal investigator
Peking University Hospital of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aggressive Periodontitis, Generalized, run by Peking University at 1 site in China.
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: finished, as of the sponsor's last update on 29 Mar 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 China. 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?
changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community) (time frame: Baseline, 6 weeks after mechanical treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03090282, which also lists 1 linked publication.
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 29 Mar 2023.