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Compares treatment options for Guided Tissue Regeneration, Periodontal / Methods
Official title Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
ClinicalTrials.gov ID: NCT07339605
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Periodontitis stage III or IV, grade A or B (Tonetti et al., 2017): attachment loss ≥ 5mm, radiographic bone loss extending to to the middle third...
- Older adults ≥ 18 years. The number per sex shall be balanced.
- Plaque index (PI) \< 1 following initial periodontal therapy and hygiene instructions.
- Bleeding on probing (BoP) ≤ 10%.
- Only patients with optimal compliance, assessed during etiological therapy, will be selected.
You likely can't join if
- The participant is pregnant, breastfeeding or plans to become pregnant in the next 6 months.
- Smoking ≥10 cigarettes/day.
- Daily alcohol intake \> 4U.
- Chronic illness or reduced mental capacity that may influence compliance with the protocol.
- Medications or drugs that alter the patient's healing or with concomitant oral manifestations that, in the opinion of the investigator, could...
- Systemic diseases that may influence treatment such as diabetes mellitus or rheumatoid disease.
See the full eligibility criteria
- Periodontitis stage III or IV, grade A or B (Tonetti et al., 2017): attachment loss ≥ 5mm, radiographic bone loss extending to to the middle third and beyond, tooth loss ≥4 due to periodontitis, probing depth (PD) ≥ 6mm.
- Older adults ≥ 18 years. The number per sex shall be balanced.
- Plaque index (PI) \< 1 following initial periodontal therapy and hygiene instructions.
- Bleeding on probing (BoP) ≤ 10%.
- Only patients with optimal compliance, assessed during etiological therapy, will be selected.
- At least a 2-3 wall interproximal bone defect with a radiographically moderate or deep intrabony defect (≥3mm), PD≥ 6mm using a Williams probe on uniradicular teeth or mandibular molars without furcation involvement...
- Vital teeth or teeth with well-performed root canal treatment.
- Absence of caries, prosthetic restoration or periapical infection in the tooth to be regenerated.
- Absence of systemic pathology.
- Negative history of pregnancy.
- Signed informed consent.
- The participant is willing and able to comply with the necessary visits for the treatments and evaluations scheduled during the clinical study.
- The participant is pregnant, breastfeeding or plans to become pregnant in the next 6 months.
- Smoking ≥10 cigarettes/day.
- Daily alcohol intake \> 4U.
- Chronic illness or reduced mental capacity that may influence compliance with the protocol.
- Medications or drugs that alter the patient's healing or with concomitant oral manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or how well it works.
- Systemic diseases that may influence treatment such as diabetes mellitus or rheumatoid disease.
- Allergies to drug compounds.
- Antibiotic intake 3 months prior to the start of the study or systemic condition requiring antibiotic coverage at the time of periodontal treatment.
- Periodontal treatment 6 months prior to the start of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.