Flapless Application of Enamel Matrix Derivative in Class II Mandibular Furcation Defects (NCT05541614) | Clinical Trial Compass
UnknownNot Applicable
Flapless Application of Enamel Matrix Derivative in Class II Mandibular Furcation Defects
Greece44 participantsStarted 2022-10-15
Plain-language summary
Patients diagnosed with stage III or IV periodontitis that exhibit mandibular first or second molars with increased periodontal probing depth (PPD \> 4 mm) and class II buccal mandibular furcation defects (horizontal probing depth of \>= 3 mm ) will be recruited. This study will be a non-inferiority, prospective, randomized, double-blind controlled clinical trial with a parallel design. Patient will be recruited from the clinics of the School of Dentistry at the Aristotle University of Thessaloniki and private dental practices in Thessaloniki, Greece. Initially, non-surgical periodontal treatment will be performed through scaling and root planning in combination with oral hygiene instructions and motivation. The re-evaluation will be performed 4-6 weeks following the treatment and the patients who meet the inclusion criteria will be included in the study. Patients will be randomly allocated at a 1:1 ratio to either subgingival debridement and flapless application of EMD (test group) into the affected furcation defect or to periodontal surgery in combination with EMD application (control group). Periodontal and radiographic parameters, patient reported outcomes, oral cavity measurements and gingival crevicular fluid will be collected before as well as up to 9 months following the treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals of at least 18 years of age with a diagnosis of stage III or IV periodontitis.
* Have at least one class II furcation defect with PPD \>4 mm and horizontal probing depth of \>= 3 mm in a mandibular first or second molar.
* Teeth have to be vital or properly treated endodontically.
* Gingival recession ≤ 2mm on furcation site
* Proper oral hygiene: full-mouth plaque score (FMPS) ≤20%.
* Systemically healthy (absence of systemic conditions such as diabetes mellitus that can affect the treatment outcome of periodontal therapy)
* Ability to understand the study procedures and comply with them through the length of the study.
* Given written informed consent form for participation in the study.
Exclusion Criteria:
* Pregnant or lactating female (self-reported).
* Current acute infection.
* Non-surgical periodontal treatment within the last 6 months or/and surgical periodontal treatment the last 12 months before the initial pre-treatment.
* Need for antibiotic premedication.
* Antibiotic treatment in the previous 3 months.
* Allergy to any materials or medications that could be used during or after the procedure.
* Teeth having an improper endodontic therapy with clinical signs of infection or subgingival restorations.
* Tooth mobility of 2nd and 3rd degree.
* History of radiation therapy in the head and neck region.
* Chronic use of medications that may alter the response of periodontal tissues.
* Smoke ≥ 10 cigarettes/day.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.