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New treatment option for Periodontal Diseases
Official title Hyaluronic Acid and Polynucleotides for Supra-bony Defects
ClinicalTrials.gov ID: NCT06309719
What this study is testing
What is Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA)?
Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for periodontal diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel.
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
- Systemically healthy males and females ≥18 years old
- Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)
- Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by...
- Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months
- Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%
You likely can't join if
- Teeth with degree III mobility
- Multi-rooted teeth with grade ≥2 furcation involvement
- Heavy smokers (≥10 cigarettes a day)
- Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery
- Previous periodontal surgery in the area selected for the study
- History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)
See the full eligibility criteria
- Systemically healthy males and females ≥18 years old
- Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)
- Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by a predominantly horizontal pattern of tissue destruction) confirmed...
- Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months
- Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%
- Teeth with degree III mobility
- Multi-rooted teeth with grade ≥2 furcation involvement
- Heavy smokers (≥10 cigarettes a day)
- Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery
- Previous periodontal surgery in the area selected for the study
- History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)
- Antibiotic or anticoagulant therapy during the month preceding the baseline exam.
- History of alcohol or drug abuse
- Medical history that includes uncontrolled diabetes or hepatic or renal diseases, or other serious medical conditions that can have a negative impact on the periodontal condition
- In treatment with medications that can severely affect bone metabolism and blood clot formation (e.g., anticoagulants, long-term corticosteroids, bisphosphonates, immunosuppressants)
- Self-reported pregnancy or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
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 London, United Kingdom. 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.