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Salivary extracellular vesicles cargo profile in wound healing in adults following alveolar ridge preservation or unassisted healing

Salivary extracellular vesicles cargo profile in wound healing in adults following alveolar ridge preservation or unassisted healing

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000067370
Enrollment
116
Registered
2026-01-19
Start date
2026-01-26
Completion date
2030-12-30
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This observational clinical study investigates changes in salivary host-derived extracellular vesicles (EVs) following tooth extraction with or without alveolar ridge preservation (ARP) using Bio-Oss Collagen and Bio-Gide. Saliva samples will be collected longitudinally at baseline and multiple post-operative time points, including during early healing, pre-implantation, and post-implantation phases, and analyzed saliva extracellular vesicles using proteomic, lipidomic, and metabolomic approaches. For all participants, a socket biopsy samples with both soft and bone tissues obtained during routine implant placement will be assessed histomorphometrically and correlated with salivary EV profiles. Post-implantation patients will be followed up for 6-months to monitor periodontal status and saliva extracellular vesicles profiles.

Interventions

Alveolar Ridge Preservation (ARP; Bio-Oss Collagen, and BioGide) post-tooth extraction -This observational study evaluates patients undergoing tooth extraction followed by Alveolar Ridge Preservation (ARP) using Bio-Oss Collagen (xenogeneic bone substitute) and Bio-Gide (resorbable collagen membrane) as part of routine clinical care. -The primary exposure is the surgical intervention of tooth extraction with ARP, and the condition observed is the biological response reflected by changes in saliv

Alveolar Ridge Preservation (ARP; Bio-Oss Collagen, and BioGide) post-tooth extraction -This observational study evaluates patients undergoing tooth extraction followed by Alveolar Ridge Preservation (ARP) using Bio-Oss Collagen (xenogeneic bone substitute) and Bio-Gide (resorbable collagen membrane) as part of routine clinical care. -The primary exposure is the surgical intervention of tooth extraction with ARP, and the condition observed is the biological response reflected by changes in salivary extracellular vesicles (EVs). EVs are nano-sized vesicles involved in intercellular communication and may reflect local tissue healing, inflammation, and bone remodeling processes following ARP. -No experimental treatment is administered; all procedures are performed according to standard clinical indications. The following observational data will be collected: -Saliva samples collected at predefined time points (baseline, 1 w, 2w, 4 weeks and 16 weeks post-APR and 3- and 6-month post dental implant for APR group; baseline, 1 w, 2w, 4 and 8 weeks post-extraction and 3- and 6-month post dental implant for extraction group); for isolation and analysis of extracellular vesicles (e.g., EV concentration, size distribution, surface markers, and cargo such as proteins or nucleic acids). -Clinical data using periodontal charting for periodontal health obtained, including: Patient demographics (age, sex); all clinical parameters of periodontal health; Tooth extraction site and indication; ARP materials used (Bio-Oss Collagen and Bio-Gide); Relevant medical and dental history; Smoking status and oral hygiene status (if available) -Clinical healing parameters, such as soft tissue healing index, presence of complications and other relevant parameters, as routinely documented during follow-up visits. -No blood samples are collected. -4 months post-ARP and 2-month post-extraction groups, a core biopsy from the socket consisting both soft and bone (often a waste tissue discarded during routine surgery) by a 2.5mm diameter trephine bur will be collected from all groups for histological, immunochemistry, microCT, proteome, single RNA-sequencing, spatial transcriptome and other relevant assessments to assess bone anf soft tissue healing -Saliva collection will occur at multiple predefined time points, for example: ---ARP group: saliva samples will be collected at baseline (prior to tooth extraction), and at 1 week, 2 weeks, 4 weeks, and 16 weeks post–alveolar ridge preservation (ARP), as well as at 3 months and 6 months following dental implant placement. ---Extraction-only group: saliva samples will be collected at baseline (prior to tooth extraction), and at 1 week, 2 weeks, 4 weeks, and 8 weeks post-extraction, as well as at 3 months and 6 months following dental implant placement. -A swab sample from the extracted tooth site for both groups will be collected using a cotton bud or relevant clinical tool. -Data collection is limited to the routine follow-up schedule, and no long-term monitoring beyond standard clinical care is required. -Pre-implant, 3-month and 6-month post-implants, saliva, PICF (peri-implant crevicular fluid) samples and periodontal chart clinical data will be collected

Sponsors

The University of Queensland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults (greater than or equal to 18 years) requiring ARP or tooth extraction (for single-rooted, single-tooth extraction); fenestration + dehiscence < 50% root length [1]; No history of severe systemic disease (e.g., uncontrolled diabetes); Non-smokers; No recent antibiotic or anti-inflammatory use. Ref 1. Nalbantoglu, A.M. and D. Yanik, Fenestration and dehiscence defects in maxillary anterior teeth using two classification systems. Aust Dent J, 2023. 68(1): p. 48-57.

Exclusion criteria

Severe periodontal disease or advanced bone loss; Immunocompromised patients; uncontrolled diabetes; Pregnancy or lactation; having a history of head and neck radiotherapy and smoking >10 cigarettes/day

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026