Edentulism in Lower JawNCT06807944
Association Between Salivary Soluble RANKL, OPG Concentration and Mandibular Resorption to Clinically Predict Severe Residual Ridge Resorption Risk
An observational study of Edentulism in Lower Jaw, run by Nguyen Thu Thuy at 1 site in Vietnam.
Trial summary
Background. Affecting all individuals, residual ridge resorption (RRR) is a prevalent, progressive condition developing post tooth loss, often remaining silent until denture instability occurs. The molecular mechanisms and predictive bone biomarkers for severe RRR in edentulous individuals are poorly understood. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulism in Lower Jaw
- How many people
- 140 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Nov 2021to 1 Apr 2024
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Edentulous participants seeking oral care and treatment at the Faculty of Dentistry Clinic of the University of Medicine and Pharmacy Ho Chi Minh City from November 2021 to April 2024.
Who may be able to join
- complete edentulism for more than 3 years
- age > 35 years old
- no history of bone augmentation or mandibular defects
Who cannot join
- systemic diseases known to affect bone metabolism or immune function
- a history of malignancy
- salivary gland disease
- using antibiotics or immunosuppressant medications within 3 months
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Dentistry, University of Medicine and Pharmacy Ho Chi Minh City, Viet Nam
Ho Chi Minh City
About this study
Background. Affecting all individuals, residual ridge resorption (RRR) is a prevalent, progressive condition developing post tooth loss, often remaining silent until denture instability occurs. The molecular mechanisms and predictive bone biomarkers for severe RRR in edentulous individuals are poorly understood.
Object.This study aimed to investigate:
- The association between salivary soluble Receptor activator of nuclear factor-κB ligand (RANKL), osteoprotegerin (OPG) concentration and the extent of mandibular resorption
- Propose a way to clinically predict severe RRR risk. Methods.This cross-sectional study, conducted at the Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam (November 2021 to April 2024), enrolled 140 systemically healthy, edentulous adults (mean age 69.2 ± 8 years). Participants were stratified into atrophic (n=70) and non-atrophic (n=70) groups based on mandibular height. Demographic data (age, sex), edentulous duration, and denture history were recorded. Unstimulated whole saliva samples (5 mL) were collected, and salivary RANKL and OPG concentrations were quantified by ELISA.
Read the detailed description
This cross-sectional study was approved by the Ethical Committee Board of the University of Medicine and Pharmacy in Ho Chi Minh City (UMP) (No.488/HĐĐĐ-ĐHYD), recruited participants between November 2021 and April 2024. All participants provided informed and written consent before clinical examinations and saliva. A convenience sampling method was employed. Of the 254 potential edentulous participants, 140 participants were included in the study.
Participant grouping: Participants underwent panoramic radiography to assess mandibular ridge height. They were classified into two groups. Atrophic groups have mandibular ridge heights less than 25 mm anteriorly and less than 16 mm posteriorly. In the non-atrophic group, mandibular ridge height is ≥ 25 mm anteriorly and ≥ 16 mm posteriorly.
Clinical factors: The participant's age, sex, duration of edentulism, and past complete denture experience were collected by the patient or patient's relative interview.
To obtain unstimulated whole saliva from each participants, approximately 5 ml was collected. Before the collection, all participants were instructed to refrain from eating and drinking for at least 30 minutes. Between 7:00 and 8:00 a.m., the collection was conducted through expectoration into sterile polypropylene tubes. Immediately after collection, the samples were placed in a cool box containing an ice pack and then hand-delivered to the Center for Molecular Biomedicine at UMP, Ho Chi Minh City, Vietnam.
RANKL and OPG salivary levels were measured using enzyme-linked immunosorbent assay Data analysis, including the relationship between RANKL, OPG and other variables, and the development of a predictive nomogram for high-risk bone resorption, was performed using R language version 3.4.0.
- Conditions
- Edentulism in Lower Jaw
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 |
|---|---|---|
| Atrophic mandibular ridge | Not described | |
| Non-Atrophic mandibular ridge | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration level of nuclear factor-κB ligand (RANKL)
It is measured using enzyme-linked immunosorbent assay (ELISA) kits (CSBE05125h, Cusabio, China ) mixing with the participant saliva
Measured: within 6 months after sample collection
The concentration level of osteoprotegerin (OPG)
It is measured using enzyme-linked immunosorbent assay (ELISA) kits (CEHTNFRSF11B, Invitrogen, Massachusetts, USA ) mixing with the participant saliva
Measured: within 6 months after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start30 Nov 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism in Lower JawStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nguyen Thu Thuy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nguyen Thu Thuy, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807944
- Sponsor's protocol ID
- 488/HĐĐĐ-DHYD
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy concern
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Salivary Soluble RANKL, OPG Concentration and Mandibular Resorption to Clinically Predict Severe Residual Ridge Resorption Risk
- ClinicalTrials.gov ID
- NCT06807944
- Acronym / sponsor ID
- 488/HĐĐĐ-DHYD
- Conditions
- Edentulism in Lower Jaw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Nguyen Thu ThuyUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 4 Feb 2025 (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.
Background. Affecting all individuals, residual ridge resorption (RRR) is a prevalent, progressive condition developing post tooth loss, often remaining silent until denture instability occurs. The molecular mechanisms and predictive bone biomarkers for severe RRR in edentulous individuals are poorly understood.
Object.This study aimed to investigate:
- The association between salivary soluble Receptor activator of nuclear factor-κB ligand (RANKL), osteoprotegerin (OPG) concentration and the extent of mandibular resorption
- Propose a way to clinically predict severe RRR risk. Methods.This cross-sectional study, conducted at the Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam (November 2021 to April 2024), enrolled 140 systemically healthy, edentulous adults (mean age 69.2 ± 8 years). Participants were stratified into atrophic (n=70) and non-atrophic (n=70) groups based on mandibular height. Demographic data (age, sex), edentulous duration, and denture history were recorded. Unstimulated whole saliva samples (5 mL) were collected, and salivary RANKL and OPG concentrations were quantified by ELISA.
Detailed description
This cross-sectional study was approved by the Ethical Committee Board of the University of Medicine and Pharmacy in Ho Chi Minh City (UMP) (No.488/HĐĐĐ-ĐHYD), recruited participants between November 2021 and April 2024. All participants provided informed and written consent before clinical examinations and saliva. A convenience sampling method was employed. Of the 254 potential edentulous participants, 140 participants were included in the study.
Participant grouping: Participants underwent panoramic radiography to assess mandibular ridge height. They were classified into two groups. Atrophic groups have mandibular ridge heights less than 25 mm anteriorly and less than 16 mm posteriorly. In the non-atrophic group, mandibular ridge height is ≥ 25 mm anteriorly and ≥ 16 mm posteriorly.
Clinical factors: The participant's age, sex, duration of edentulism, and past complete denture experience were collected by the patient or patient's relative interview.
To obtain unstimulated whole saliva from each participants, approximately 5 ml was collected. Before the collection, all participants were instructed to refrain from eating and drinking for at least 30 minutes. Between 7:00 and 8:00 a.m., the collection was conducted through expectoration into sterile polypropylene tubes. Immediately after collection, the samples were placed in a cool box containing an ice pack and then hand-delivered to the Center for Molecular Biomedicine at UMP, Ho Chi Minh City, Vietnam.
RANKL and OPG salivary levels were measured using enzyme-linked immunosorbent assay Data analysis, including the relationship between RANKL, OPG and other variables, and the development of a predictive nomogram for high-risk bone resorption, was performed using R language version 3.4.0.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrophic mandibular ridge | – | – |
| Non-Atrophic mandibular ridge | – | – |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Edentulous participants seeking oral care and treatment at the Faculty of Dentistry Clinic of the University of Medicine and Pharmacy Ho Chi Minh City from November 2021 to April 2024.
Key inclusion criteria (3 listed)
- complete edentulism for more than 3 years
- age > 35 years old
- no history of bone augmentation or mandibular defects
Key exclusion criteria (4 listed)
- systemic diseases known to affect bone metabolism or immune function
- a history of malignancy
- salivary gland disease
- using antibiotics or immunosuppressant medications within 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.
Primary outcome
The concentration level of nuclear factor-κB ligand (RANKL)
Time frame: within 6 months after sample collection
It is measured using enzyme-linked immunosorbent assay (ELISA) kits (CSBE05125h, Cusabio, China ) mixing with the participant saliva
The concentration level of osteoprotegerin (OPG)
Time frame: within 6 months after sample collection
It is measured using enzyme-linked immunosorbent assay (ELISA) kits (CEHTNFRSF11B, Invitrogen, Massachusetts, USA ) mixing with the participant saliva
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 4 Feb 2025.
- Individual participant dataSharing planned: No. Privacy concern
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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 Edentulism in Lower Jaw, run by Nguyen Thu Thuy 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 3 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 4 Feb 2025. 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?
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?
The concentration level of nuclear factor-κB ligand (RANKL) (time frame: within 6 months after sample collection). 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 4 Feb 2025.