Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 1:27 AM
Study NCT ID:
NCT07339605
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Sponsor:
University of Valencia
Organization:
Study Overview
Official Title:
Clinical and Radiographic Outcomes After Flapless Approach of Intrabony Defects With the Application of Enamel Matrix Derivative Versus Hyaluronic Acid: A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to radiographically assess the effectiveness of minimally invasive non-surgical technique (MINST) combined with local administration of sodium hypochlorite gel (Perisolv®) and 1.6% cross-linked hyaluronic acid (HA, Hyadent BG®) compared to a neutral formulation of EDTA (Prefgel®) and enamel matrix derivative (EMD, Emdogain® FL) in periodontal regeneration. The main questions it aims to answer are:
* ¿Does the combination of MINST with the local administration of sodium hypochlorite gel and 1.6% cross-linked hyaluronic acid show a potential for periodontal regeneration similar to evaluating clinical and radiographic variables compared to a neutral formulation of EDTA and enamel matrix derivative?
* ¿What is the patient perception and satisfaction with the received treatment?
Researchers will compare A (MINST with Perisolv® + Hyadent BG®), B (MINST with PrefGel® + Emdogain® FL) and C(MINST without any bioactive product).
The sample will be distributed according to the following treatments:
* Experimental group: Scaling and root planing (SRP), MINST with Perisolv® + Hyadent BG®.
* Active comparator group: SRP, MINST with PrefGel® + Emdogain® FL.
* Control group: SRP, MINST without any bioactive product.
Patients will be screened by a first visit in which they will be assigned their periodontal status. If they meet the eligibility criteria, they will be treated according to the EFP clinical guideline for periodontitis treatment: step I and step II.If the periodontal defect persists at the 12-week re-evaluation, patients will be randomised to treatment A, B or C.
After the intervention, all participants will be checked weekly for the first 6 weeks to remove accumulated plaque, and every 3 months for 1 year. Periodontal parameters will be re-evaluated 6 and 12 months after periodontal regenerative intervention.
* ¿Does the combination of MINST with the local administration of sodium hypochlorite gel and 1.6% cross-linked hyaluronic acid show a potential for periodontal regeneration similar to evaluating clinical and radiographic variables compared to a neutral formulation of EDTA and enamel matrix derivative?
* ¿What is the patient perception and satisfaction with the received treatment?
Researchers will compare A (MINST with Perisolv® + Hyadent BG®), B (MINST with PrefGel® + Emdogain® FL) and C(MINST without any bioactive product).
The sample will be distributed according to the following treatments:
* Experimental group: Scaling and root planing (SRP), MINST with Perisolv® + Hyadent BG®.
* Active comparator group: SRP, MINST with PrefGel® + Emdogain® FL.
* Control group: SRP, MINST without any bioactive product.
Patients will be screened by a first visit in which they will be assigned their periodontal status. If they meet the eligibility criteria, they will be treated according to the EFP clinical guideline for periodontitis treatment: step I and step II.If the periodontal defect persists at the 12-week re-evaluation, patients will be randomised to treatment A, B or C.
After the intervention, all participants will be checked weekly for the first 6 weeks to remove accumulated plaque, and every 3 months for 1 year. Periodontal parameters will be re-evaluated 6 and 12 months after periodontal regenerative intervention.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: