Non-surgical vs. Surgical Therapy for Periodontal Furcations

NCT05237401 | Active Not Recruiting

• 1 other identifier: 222112021
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 5-year tooth survival

  to test the survival of the tooth with advanced furcation after 5 years

  5 years

Secondary Outcomes (16)

• Maximum Pocket depth (PPD)

  5 years

• Maximum Clinical attachment level CAL

  5 years

• Radiographic bone levels

  5 years

• Patient's discomfort measurement

  5 years

• Time needed for each study appointment during maintenance therapy

  5 years

Study Arms (2)

Non-Surgical Periodontal treatment (NSPT)

ACTIVE COMPARATOR

Half of the study participants (controls) will be randomised to receive continued non-surgical periodontal treatment (NSPT). All treatment will be carried out by the same therapist in each centre, including oral hygiene.

Procedure: Non-Surgical Periodontal treatment (NSPT)

Surgical Periodontal treatment/ Open Flap Debridement (OFD)

EXPERIMENTAL

The other half of the study participants (test) will be randomised to receive surgical periodontal treatment in the form of open flap debridement (OFD). The aim of the surgery will be to achieve thorough debridement of the furcation area and (if possible) improve accessibility for patient-performed hygiene in the furcation area. Some of the included maxillary molars may have additional FI on the same tooth (for example, grade III FI buccal to mesial and grade I, II or III distal). In this occurrence, the other furcation will be treated according to judgment by the treating clinician. We anticipate that, based on inclusion criteria, the majority of cases will have multiple grade III FI.

Procedure: Surgical Periodontal treatment/ Open Flap Debridement (OFD)

Interventions

Non-Surgical Periodontal treatment (NSPT) PROCEDURE

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.

Non-Surgical Periodontal treatment (NSPT)

Surgical Periodontal treatment/ Open Flap Debridement (OFD) PROCEDURE

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.

Surgical Periodontal treatment/ Open Flap Debridement (OFD)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 examining clinician

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Furcation Defects; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Luigi Nibali

  King's College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 14, 2022
• Study Start: April 21, 2022
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 30, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)