Non-surgical vs. Surgical Therapy for Periodontal Furcations (NCT05237401) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Non-surgical vs. Surgical Therapy for Periodontal Furcations
United Kingdom59 participantsStarted 2022-04-21
Plain-language summary
Periodontitis is an inflammatory disease of the tooth-supporting apparatus, which leads to attachment and bone loss and eventually to tooth loss if treatment is not provided.
When the periodontitis-related bone loss affects the area of root separation in molars, a furcation involvement (FI) is created. This represents a challenge in the treatment of periodontally-compromised molars, affecting the majority of patients with periodontitis. Based on a prevalence of severe forms of periodontitis in the UK and worldwide of about 10% of the population and on previous studies, we can assume that at least 5-10% of the general population are affected by FI.
Different treatment modalities are advocated for the treatment of FI, including non-surgical maintenance, resective (bone recontouring) and regenerative (reconstruction of bone and attachment) surgical treatments or tooth extraction. It has clearly emerged that FI at least doubles the risk of tooth loss. However, in the case of advanced through-and-through loss of attachment and bone in the furcation area (FI degree III), the clinician is often faced with a very difficult treatment decision, without being able to draw on much evidence from the literature. Interestingly, there are no randomised controlled trials exploring the most appropriate treatment for advanced furcation involvement. This has been highlighted in a recent systematic review commissioned by the European Federation of Periodontology.
Who can participate
Age range
18 Years – 85 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:
* Minimum of 12 teeth present
* Diagnosis of Severe Periodontitis stage III or IV
* At least one maxillary/ mandibular molar with: i) degree III horizontal furcation involvement (at least between 2 roots for maxillary molars) , ii) class B vertical furcation involvement (bone loss up to the middle third of root cones), iii) residual probing pocket depths \> 5 mm in furcation area, iv) maximum mobility degree Iand v) not already accessible for self-performed oral hygiene
* Received a course of non-surgical periodontal therapy within the past six months
Exclusion Criteria:
Patient:
* Full mouth plaque score \> 30%
* A course of antibiotics within the past 3 months
* Pregnant/lactating women
* Relevant medical history as evaluated by the examining clinician which may have the potential to affect periodontal surgical treatment
* Individuals on long-standing (2 or above years) supportive periodontal therapy (SPT) management plans
Molar affected by FI:
* Ongoing endodontic pathology affecting the furcation involved molar, as judged by the examining clinician
* Previous periodontal surgical treatment to the furcation affected molar within the previous 5 years
* Endodontically treated molar tooth without a full coverage restoration
* 'Unrestorable' molar tooth (lacking adequate tooth structure to provide a restoration) as deemed by the examining clinician.
* Molar tooth acting as a bridge abutment
* The presence of occlusal dysfunction as assessed by the exa…
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.