Treatment of Advanced Grade III Periodontal Furcation Lesions

NCT05237739 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-06

No results posted yet for this study

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

Interventions

PROCEDURE

Non-Surgical Periodontal treatment (NSPT)

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.

PROCEDURE

Open Flap Debridement (OFD)

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

Sponsors & Collaborators

Principal Investigators

  • Luigi Nibali · Floor 18, Tower Wing Guy's Hospital London SE1 9RTN/A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-05
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05237739 on ClinicalTrials.gov