Non-surgical vs. Surgical Therapy for Periodontal Furcations
NCT05237401 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2025-09-30
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.
Conditions
- Furcation Defects
- Periodontitis
- Surgical Procedure, Unspecified
Interventions
- PROCEDURE
-
Non-Surgical Periodontal treatment (NSPT)
participants will receive local anaesthesia, then thorough debridement of the root surface will be completed to the depth of the periodontal pocket and of the furcation lesion, by using sonic scaler (KaVo Sonicflex, KaVo, Germany), piezo-electric/ultrasonic devices with specific thin and delicate tips (such as Cavitron, Dentsply Sirona, US) and/or curettes.
- PROCEDURE
-
Surgical Periodontal treatment/ Open Flap Debridement (OFD)
Patients will receive local anaesthesia and intrasulcular incisions will be made on the buccal and lingual/palatal aspects in order to reflect full-thickness flaps. After reflection of the flaps, the granulation tissue around the tooth will be removed with the non-cutting edge of a suitable scaling instrument such as a curette, taking care not to damage the root surfaces. Thorough debridement of the furcation area will be carried out by using diamond coated inserts, sonic scaler (KaVo Sonicflex, KaVo, Germany), piezo-electric/ultrasonic devices with specific thin and delicate tips (such as Cavitron, Dentsply Sirona, US) and/or curettes. Osteoplasty (removal of non-supporting bone) may be carried out, as judged by the operator. The surgical site will be closed with resorbable or non-resorbable sutures.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Luigi Nibali · King's College London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-21
- Primary Completion
- 2029-01-31
- Completion
- 2029-01-31
Countries
- United Kingdom
Study Locations
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