PeriodontitisNCT07705048
PTPIP51-VAPB Complex in the Periodontal Disease
An observational study of Periodontitis and Gingivitis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Gum disease, including gingivitis and more advanced periodontitis, is a common condition that damages the tissues supporting the teeth. This study looks at how gum disease affects specific proteins inside gum tissue cells that help control how cells communicate between their internal structures and clean out damaged… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 Jul 2024
- How long will I take part?
- 1 Day
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults aged 18 to 60 years attending the periodontology clinic were enrolled and classified into three groups based on clinical periodontal parameters according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III). Exclusion criteria included any systemic disease, regular medication use, smoking, pregnancy or lactation, periodontal treatment within the past 6 months, antibiotic use within the past 6 months, and presence of prosthetic restorations on the teeth to be sampled. A total of 60 participants (20 per group; 30 male, 30 female) were included.
Who may be able to join
- Inclusion criteria for the Healthy Control group were: presence of ≥ 20 teeth in the mouth, probing pocket depth (PPD) ≤ 3 mm, the percentage of bleeding sites for the whole mouth < 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Gingivitis group were: presence of ≥ 20 teeth in the mouth, PPD ≤ 3 mm, % of bleeding sites for the whole mouth ≥ 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Stage 3 Periodontitis group were: presence of ≥ 15 teeth in the mouth, more than 30% of teeth affected by periodontal disease, affected teeth exhibiting probing depths of 6 mm or more and clinical attachment loss (CAL) of ≥ 5 mm, vertical bone loss of 3 mm or more, class 2 or 3 furcation involvement, and radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth
Who cannot join
- Exclusion criteria for all groups were defined as: presence of any systemic disease, regular use of any medication, smoking, pregnancy or lactation, periodontal treatment within the last 6 months, antibiotic use within the last 6 months, and the presence of prosthetic restorations on the teeth to be sampled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of PTPIP51-VAPB Complex in the Pathogenesis of Periodontal Disease
Gum disease, including gingivitis and more advanced periodontitis, is a common condition that damages the tissues supporting the teeth. This study looks at how gum disease affects specific proteins inside gum tissue cells that help control how cells communicate between their internal structures and clean out damaged material (a process called autophagy). Researchers will collect small gum tissue samples from people with healthy gums, gingivitis, or periodontitis during dental procedures they are already having. These samples will be tested to measure the levels of three proteins (called PTPIP51, VAPB, and LC3B) and calcium. In a separate laboratory experiment, gum cells will be exposed to a substance made by bacteria commonly linked to gum disease, to see how these same proteins respond. The goal of this study is to better understand the biological changes that happen in gum tissue as gum disease develops, which may help guide future research into new treatments.
Read the detailed description
Periodontal disease encompasses a spectrum of inflammatory conditions ranging from gingivitis to periodontitis, both of which are driven by the host immune response to periodontopathogenic bacteria such as Porphyromonas gingivalis. Mitochondria-associated endoplasmic reticulum membranes (MAMs) are physical contact sites between the endoplasmic reticulum and mitochondria that regulate calcium exchange, lipid metabolism, and autophagy. The VAPB-PTPIP51 tethering complex is a key molecular determinant of MAM formation, and prior research has shown that alterations in this complex affect autophagosome formation and intracellular calcium homeostasis. However, the role of the VAPB-PTPIP51 complex and autophagy-related protein LC3B in periodontal disease has not been previously characterized.
This study includes two components. First, an observational, cross-sectional investigation was conducted in 60 participants classified into three groups (periodontal health, gingivitis, and periodontitis) according to the 2017 World Workshop classification criteria, based on clinical parameters including plaque index, gingival index, probing depth, clinical attachment level, and bleeding on probing. Gingival tissue biopsies were obtained from participants undergoing clinically indicated periodontal procedures (crown lengthening, gingivectomy, or flap surgery). Tissue samples were analyzed for gene expression (RT-PCR) and protein levels (Western blot) of PTPIP51, VAPB, and LC3B, as well as tissue calcium concentration.
Second, an in vitro experimental component was performed using a commercially available human gingival fibroblast cell line (HGF-1) treated with Porphyromonas gingivalis lipopolysaccharide (LPS) at 5 μg/mL and 10 μg/mL for 24 hours, to evaluate dose-dependent changes in PTPIP51, VAPB, and LC3B gene expression in response to a periodontopathogenic stimulus.
The findings from this study aim to clarify the involvement of the VAPB-PTPIP51 tethering complex and autophagy-related signaling in periodontal tissue destruction, providing mechanistic insight that may inform future therapeutic approaches targeting mitochondria-endoplasmic reticulum communication in periodontal disease.
- Conditions
- Periodontitis, Gingivitis
- Keywords
- periodontitis, gingivitis, mitochondria, endoplasmic reticulum
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| periodontally healthy | periodontally healthy participants | |
| gingivitis group | patients with gingivitis | |
| periodontitis | patients with periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival PTPIP51, VAPB, and LC3B Gene and Protein Expression
Gene expression (RT-PCR, relative fold change via 2^-ΔΔCT method) and protein expression (Western blot, band intensity normalized to ACTB) of PTPIP51, VAPB, and LC3B were measured and compared in gingival tissue biopsies from participants with periodontal health, gingivitis, and periodontitis
Measured: From February to July 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Feb 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Aral, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705048
- Sponsor's protocol ID
- IU-2024/13
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared, including participant age, sex, and clinical periodontal parameters (plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing). Participants will be identified only by coded/numbered case report forms; no names, gender identity beyond biological sex, or other identifying information will be shared.
Publications
Kirmizigul OA, Sabanci A, Disli F, Yildiz S, Milward MR, Aral K. Evaluation of the role of mitofusin-1 and mitofusin-2 in periodontal disease. J Periodontol. 2024 Jan;95(1):64-73. doi: 10.1002/JPER.23-0072. Epub 2023 Jul 24.
PubMed 37436713Aral K, Milward MR, Cooper PR. Gene expression profiles of mitochondria-endoplasmic reticulum tethering in human gingival fibroblasts in response to periodontal pathogens. Arch Oral Biol. 2021 Aug;128:105173. doi: 10.1016/j.archoralbio.2021.105173. Epub 2021 May 27.
PubMed 34058723Gomez-Suaga P, Paillusson S, Stoica R, Noble W, Hanger DP, Miller CCJ. The ER-Mitochondria Tethering Complex VAPB-PTPIP51 Regulates Autophagy. Curr Biol. 2017 Feb 6;27(3):371-385. doi: 10.1016/j.cub.2016.12.038. Epub 2017 Jan 26.
PubMed 28132811
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of PTPIP51-VAPB Complex in the Pathogenesis of Periodontal Disease
- ClinicalTrials.gov ID
- NCT07705048
- Acronym / sponsor ID
- IU-2024/13
- Conditions
- Periodontitis, Gingivitis
- Keywords
- periodontitis, gingivitis, mitochondria, endoplasmic reticulum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 15 Jul 2026 (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.
Gum disease, including gingivitis and more advanced periodontitis, is a common condition that damages the tissues supporting the teeth. This study looks at how gum disease affects specific proteins inside gum tissue cells that help control how cells communicate between their internal structures and clean out damaged material (a process called autophagy). Researchers will collect small gum tissue samples from people with healthy gums, gingivitis, or periodontitis during dental procedures they are already having. These samples will be tested to measure the levels of three proteins (called PTPIP51, VAPB, and LC3B) and calcium. In a separate laboratory experiment, gum cells will be exposed to a substance made by bacteria commonly linked to gum disease, to see how these same proteins respond. The goal of this study is to better understand the biological changes that happen in gum tissue as gum disease develops, which may help guide future research into new treatments.
Detailed description
Periodontal disease encompasses a spectrum of inflammatory conditions ranging from gingivitis to periodontitis, both of which are driven by the host immune response to periodontopathogenic bacteria such as Porphyromonas gingivalis. Mitochondria-associated endoplasmic reticulum membranes (MAMs) are physical contact sites between the endoplasmic reticulum and mitochondria that regulate calcium exchange, lipid metabolism, and autophagy. The VAPB-PTPIP51 tethering complex is a key molecular determinant of MAM formation, and prior research has shown that alterations in this complex affect autophagosome formation and intracellular calcium homeostasis. However, the role of the VAPB-PTPIP51 complex and autophagy-related protein LC3B in periodontal disease has not been previously characterized.
This study includes two components. First, an observational, cross-sectional investigation was conducted in 60 participants classified into three groups (periodontal health, gingivitis, and periodontitis) according to the 2017 World Workshop classification criteria, based on clinical parameters including plaque index, gingival index, probing depth, clinical attachment level, and bleeding on probing. Gingival tissue biopsies were obtained from participants undergoing clinically indicated periodontal procedures (crown lengthening, gingivectomy, or flap surgery). Tissue samples were analyzed for gene expression (RT-PCR) and protein levels (Western blot) of PTPIP51, VAPB, and LC3B, as well as tissue calcium concentration.
Second, an in vitro experimental component was performed using a commercially available human gingival fibroblast cell line (HGF-1) treated with Porphyromonas gingivalis lipopolysaccharide (LPS) at 5 μg/mL and 10 μg/mL for 24 hours, to evaluate dose-dependent changes in PTPIP51, VAPB, and LC3B gene expression in response to a periodontopathogenic stimulus.
The findings from this study aim to clarify the involvement of the VAPB-PTPIP51 tethering complex and autophagy-related signaling in periodontal tissue destruction, providing mechanistic insight that may inform future therapeutic approaches targeting mitochondria-endoplasmic reticulum communication in periodontal disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontally healthy | – | –periodontally healthy participants |
| gingivitis group | – | –patients with gingivitis |
| periodontitis | – | –patients with periodontitis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults aged 18 to 60 years attending the periodontology clinic were enrolled and classified into three groups based on clinical periodontal parameters according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III). Exclusion criteria included any systemic disease, regular medication use, smoking, pregnancy or lactation, periodontal treatment within the past 6 months, antibiotic use within the past 6 months, and presence of prosthetic restorations on the teeth to be sampled. A total of 60 participants (20 per group; 30 male, 30 female) were included.
Key inclusion criteria (1 listed)
- Inclusion criteria for the Healthy Control group were: presence of ≥ 20 teeth in the mouth, probing pocket depth (PPD) ≤ 3 mm, the percentage of bleeding sites for the whole mouth < 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Gingivitis group were: presence of ≥ 20 teeth in the mouth, PPD ≤ 3 mm, % of bleeding sites for the whole mouth ≥ 10%, and, on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth. Inclusion criteria for the Stage 3 Periodontitis group were: presence of ≥ 15 teeth in the mouth, more than 30% of teeth affected by periodontal disease, affected teeth exhibiting probing depths of 6 mm or more and clinical attachment loss (CAL) of ≥ 5 mm, vertical bone loss of 3 mm or more, class 2 or 3 furcation involvement, and radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth
Key exclusion criteria (1 listed)
- Exclusion criteria for all groups were defined as: presence of any systemic disease, regular use of any medication, smoking, pregnancy or lactation, periodontal treatment within the last 6 months, antibiotic use within the last 6 months, and the presence of prosthetic restorations on the teeth to be sampled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gingival PTPIP51, VAPB, and LC3B Gene and Protein Expression
Time frame: From February to July 2024
Gene expression (RT-PCR, relative fold change via 2^-ΔΔCT method) and protein expression (Western blot, band intensity normalized to ACTB) of PTPIP51, VAPB, and LC3B were measured and compared in gingival tissue biopsies from participants with periodontal health, gingivitis, and periodontitis
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 15 Jul 2026.
- Background: PubMed 37436713Kirmizigul OA, Sabanci A, Disli F, Yildiz S, Milward MR, Aral K. Evaluation of the role of mitofusin-1 and mitofusin-2 in periodontal disease. J Periodontol. 2024 Jan;95(1):64-73. doi: 10.1002/JPER.23-0072. Epub 2023 Jul 24.
- Background: PubMed 34058723Aral K, Milward MR, Cooper PR. Gene expression profiles of mitochondria-endoplasmic reticulum tethering in human gingival fibroblasts in response to periodontal pathogens. Arch Oral Biol. 2021 Aug;128:105173. doi: 10.1016/j.archoralbio.2021.105173. Epub 2021 May 27.
- Background: PubMed 28132811Gomez-Suaga P, Paillusson S, Stoica R, Noble W, Hanger DP, Miller CCJ. The ER-Mitochondria Tethering Complex VAPB-PTPIP51 Regulates Autophagy. Curr Biol. 2017 Feb 6;27(3):371-385. doi: 10.1016/j.cub.2016.12.038. Epub 2017 Jan 26.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared, including participant age, sex, and clinical periodontal parameters (plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing). Participants will be identified only by coded/numbered case report forms; no names, gender identity beyond biological sex, or other identifying information will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis and Gingivitis, run by Inonu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 15 Jul 2026. 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 Turkey (Türkiye). 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?
Gingival PTPIP51, VAPB, and LC3B Gene and Protein Expression (time frame: From February to July 2024). 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 NCT07705048, which also lists 3 linked publications.
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 15 Jul 2026.