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New treatment option for Periodontitis (Stage 3)
Official title Bone Substitutes and NIPSA in Intrabony Periodontal Defects: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07671963
What this study is testing
- What it's testing
- This multicenter randomized controlled clinical trial aims to compare the clinical, radiographic, microbiological and molecular outcomes of two collagenated xenogeneic bone substitutes (GTO® and GenOs®) used in combination with the Non-Incised Papilla Surgical Approach (NIPSA) for the treatment of intrabony periodontal defects. The study will evaluate whether differences exist between the two biomaterials with respect to clinical attachment gain, defect resolution, wound healing and biological markers of regeneration.
- 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 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years
- Diagnosis of Stage III periodontitis
- At least one intrabony periodontal defect with probing depth \> 5 mm following completion of non-surgical periodontal therapy
- Full-mouth plaque score (FMPS) \< 20%
- Full-mouth bleeding score (FMBS) \< 20%
You likely can't join if
- Systemic medical contraindications to periodontal surgery
- History of head and neck radiotherapy
- Poor oral hygiene or lack of motivation/compliance
- Uncontrolled diabetes mellitus
- Pregnancy or lactation
- Treatment with antiresorptive medications or other drugs affecting bone remodeling
See the full eligibility criteria
- Age ≥ 18 years
- Diagnosis of Stage III periodontitis
- At least one intrabony periodontal defect with probing depth \> 5 mm following completion of non-surgical periodontal therapy
- Full-mouth plaque score (FMPS) \< 20%
- Full-mouth bleeding score (FMBS) \< 20%
- Ability to understand the study procedures and provide written informed consent
- Systemic medical contraindications to periodontal surgery
- History of head and neck radiotherapy
- Poor oral hygiene or lack of motivation/compliance
- Uncontrolled diabetes mellitus
- Pregnancy or lactation
- Treatment with antiresorptive medications or other drugs affecting bone remodeling
- Heavy smoking (\>20 cigarettes/day)
The study team makes the final eligibility decision.
Where it's taking place
- Cagliari, Italy, Italy
- Belgrade, Serbia
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 to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cagliari, Italy, Italy; Belgrade, Serbia. 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.