- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07371130
Therapeutic Wavelength Nanotechnology Devices in Alveolar Preservation (APnanotecnolog)
Evaluation of Low-Intensity Therapeutic Wavelength Nanotechnology Devices in Alveolar Preservation: A Clinical Trial
After tooth extraction, a progressive alveolar bone resorption is observed. Alveolar ridge preservation consists of placing a biomaterial within the extraction socket and covering it with a membrane.
This procedure helps limit physiological bone resorption, making the soft and hard tissue profile of the edentulous site more prosthetically favorable.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After tooth extraction, a progressive remodeling process occurs that is often associated with significant alveolar bone resorption, particularly in sites with compromised bony walls. Alveolar ridge preservation is a surgical procedure aimed at minimizing this physiological resorption by placing grafting materials within the extraction socket and protecting them with a barrier membrane.
In the present protocol, the socket is filled with a xenogeneic bone graft enriched with hyaluronic acid, which enhances biological activity by promoting angiogenesis, cell migration, and early wound healing. The grafted site is then covered with a dermal matrix membrane, providing mechanical protection, stabilization of the biomaterial, and guided tissue regeneration.
In one study group, in addition to the surgical procedure, postoperative biostimulation using low-intensity photonic nanotechnology is applied. This adjunctive therapy is intended to enhance cellular metabolism, modulate inflammation, and accelerate both soft and hard tissue healing. The combined approach aims to preserve alveolar volume more effectively, improve the quality of regenerated tissues, and create a more favorable prosthetic environment for subsequent implant rehabilitation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Giuseppe D'Albis, Dr.
- Phone Number: +393495103642
- Email: giuseppe.dalbis@uniba.it
Study Contact Backup
- Name: Domenico Patarino, Dr.
- Phone Number: +393394359824
- Email: domenico.patarino@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults in good general health
- Indication for tooth extraction in sites planned for delayed implant placement
- Inability to place immediate post-extraction implants due to insufficient residual bone to ensure primary stability
- Extraction sockets presenting absence of the buccal (vestibular) bone wall
- Signed informed consent
Exclusion Criteria:
- Systemic conditions affecting bone healing
- Uncontrolled periodontal disease
- Smoking >10 cigarettes/day
- Pregnancy or lactation
- Use of medications interfering with bone metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Alveolar Preservation
The socket is filled with a xenogeneic bone graft enriched with hyaluronic acid and dermal membrane
|
After atraumatic tooth extraction, the socket is filled with a xenogeneic bone graft enriched with hyaluronic acid, which enhances biological activity by promoting angiogenesis, cell migration, and early wound healing.
The grafted site is then covered with a dermal matrix membrane, providing mechanical protection, stabilization of the biomaterial, and guided tissue regeneration.
|
|
Experimental: therapeutic wavelengths Alveolar Preservation
Therapeutic wavelengths are applied as part of the alveolar preservation protocol.
The extraction socket is filled with a xenogeneic bone graft enriched with hyaluronic acid and subsequently covered with a dermal membrane to support healing and tissue regeneration.
|
After atraumatic tooth extraction, the socket is filled with a xenogeneic bone graft enriched with hyaluronic acid, which enhances biological activity by promoting angiogenesis, cell migration, and early wound healing.
The grafted site is then covered with a dermal matrix membrane, providing mechanical protection, stabilization of the biomaterial, and guided tissue regeneration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analgesic consumption
Time Frame: 7 days
|
recorded as the number of ibuprofen 400 mg tablets taken
|
7 days
|
|
VAS
Time Frame: 1 day , 3 days , 7 days ,14 days
|
Postoperative pain assessment using the Visual Analog Scale (VAS) (1-10)
|
1 day , 3 days , 7 days ,14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Histological Evaluation
Time Frame: 4- 6 month
|
|
4- 6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Giuseppe D'Albis, Dr., University of Bari Aldo Moro
- Principal Investigator: Domenico Patarino, Dr., Private Practice
- Study Director: Saverio Capodiferro, Prof. Dr., University of Bari Aldo Moro
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AlveolarPreservation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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