Treatment of Advanced Grade III Periodontal Furcation Lesions

NCT05237739 | Active Not Recruiting

• 1 other identifier: 23012022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis, a microbially-driven inflammatory disease has been shown to be the sixth most common disease of mankind. The 2009 UK Adult Dental Health Survey found that 54% of adults experience gum bleeding (gingivitis) with 45% of these suffering from periodontitis. Periodontitis begins at the gingival margins of teeth and over time, in susceptible individuals, the presence of a plaque biofilm can lead to the loss of the supporting connective tissue and alveolar bone associated with the teeth. This leads to the formation of a pathological periodontal pocket between the gingiva and tooth root, measurable by the use of a periodontal probe and recorded as the probing pocket depth (PPD). The associated loss of alveolar bone support is measurable radiographically and often leads to tooth mobility and if allowed to persist, can eventually lead to tooth loss. Periodontitis is classified into 4 stages (I-IV) based on disease severity and 3 grades (A-B-C) based on risk of disease progression. The treatment of periodontitis involves a non-specific reduction of the bacterial load below the gingival margin. This is achieved by effective oral hygiene procedures and non-surgical periodontal therapy (NSPT), both of which are aimed at the removal of calculus (tartar) deposits and the disruption of the plaque biofilm from the affected root surfaces. In some cases, this treatment may then be followed by more invasive treatments such as periodontal surgery and if successful, patients can then be followed and maintained with supportive periodontal maintenance therapy (SPT). It should be noted that certain periodontal lesions in some patients do not however always respond favourably to treatment.

Conditions

Furcation Defects; Periodontitis; Surgical Procedure, Unspecified; Periodontal Bone Loss

Outcome Measures

Primary Outcomes (6)

• Number of patients

  Number of participants recruited and retained into the study

  13 months

• Number of responsive and non-responsive

  Number of participants deemed responsive and non-responsive to different treatments. Questionnaire will be used to assess the responsiveness to each treatment.

  13 months

• Number of participants randomised

  Number of participants willing to be randomised to treatment II of the study (if deemed non-responsive following treatment I). Yes or Not answer to randomisation will be used to assess this number.

  13 months

• patient-reported outcomes (Pros)

  A self-administered questionnaire will be used to assess the patient-reported outcomes (PROS) at 6 and 12 months based on different treatment arms

  13 months

• Probing Pocket Depth (PPD)

  Distance between gingival margin and the bottom of the pocket, measured in mm

  13 months

• Bleeding on probing (BOP)

  Bleeding after probing with the periodontal probe the gingival margin, 0 no bleeding 1 bleeding.

  13 months

Secondary Outcomes (1)

• Microbiological analysis

  13 months

Study Arms (2)

Test Group

EXPERIMENTAL

Ten participants will be randomised to receive surgical periodontal treatment in the form of open flap debridement (OFD).

Procedure: Open Flap Debridement (OFD)

Control Group

ACTIVE COMPARATOR

Ten participants will be randomised to receive non-surgical periodontal treatment (NSPT). All treatment will be carried out by the same therapist, including oral hygiene.

Procedure: Non-Surgical Periodontal treatment (NSPT)

Interventions

Non-Surgical Periodontal treatment (NSPT) PROCEDURE

Participants will receive local anesthesia. Thorough debridement of the root surface will be completed to the depth of the periodontal pocket and of the furcation lesion, by using piezo-electric/ultrasonic devices with specific thin and delicate tips (such as Cavitron, Dentsply Sirona, US) and/or curettes. Treatment chair time will be recorded for each visit.

Control Group

Open Flap Debridement (OFD) PROCEDURE

Patients will receive local anesthesia and intrasulcular incisions will be made by 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 piezo-electric/ultrasonic devices with specific thin and delicate tips

Test Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70
• Diagnosis of Periodontitis stage III or IV, grade A, B or C
• At least one maxillary or mandibular molars with:
• Furcation involvement grade III horizontal classification degree B-C vertical classification without any ongoing restorative problems as judged by the study clinician)
• Probing depth ≥ 6mm
• Mobility \< degree II (as examined by the study clinician)
• Absence of any ongoing endodontic pathology (as examined by the study clinician)
• Absence of an adjacent tooth with unfavorable periodontal prognosis (as judged by the study clinician)
• Non-surgical periodontal therapy performed to the study site within the last 6 months.
• Able to consent to study participation

You may not qualify if:

• Smoking (any current or in past 5 years)
• Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases
• History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
• Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
• Systemic antibiotic therapy during the 3 months preceding the baseline exam
• History of alcohol or drug abuse
• . Self-reported pregnancy or lactation
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation
• Previous surgical periodontal performed to the study site.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Furcation Defects; Periodontitis; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Officials

• Luigi Nibali

  Floor 18, Tower Wing Guy's Hospital London SE1 9RTN/A

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Simple randomisation will be completed using the online programme, Sealed Envelope. This will be completed by a member of the research team not involved in this specific study. Sealed Envelope will provide a randomisation schedule, patient numbering and a sequence of patient number assignment. This will all be safely stored and secured. The treatment allocation will be communicated to the study therapist/nurse and patient when booking the treatment appointment. It will not be possible to blind the participants or the clinician completing the study treatment. The study examiner will remain blind to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-centre single-masked randomised controlled feasibility trial with SMART design to assess the response to treatment for degree III periodontal furcation involved molars (n=20).

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 14, 2022
• Study Start: February 5, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)