Association Between Salivary Soluble RANKL, OPG Concentration and Mandibular Resorption to Clinically Predict Severe Residual Ridge Resorption Risk

NCT06807944 | Completed

• 1 other identifier: 488/HĐĐĐ-DHYD
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. Object.This study aimed to investigate:

1. 1.The association between salivary soluble Receptor activator of nuclear factor-κB ligand (RANKL), osteoprotegerin (OPG) concentration and the extent of mandibular resorption
2. 2.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.

Conditions

Edentulism in Lower Jaw

Outcome Measures

Primary Outcomes (2)

• 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

  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

  within 6 months after sample collection

Study Arms (2)

Atrophic mandibular ridge

Non-Atrophic mandibular ridge

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• complete edentulism for more than 3 years
• age \> 35 years old
• no history of bone augmentation or mandibular defects

You may not qualify if:

• 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

Sponsors & Collaborators

• Nguyen Thu Thuy: lead

Study Sites (1)

Faculty of Dentistry, University of Medicine and Pharmacy Ho Chi Minh City, Viet Nam

Ho Chi Minh City, Vietnam

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof., DDS., PhD

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: November 30, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)