Air-polishing or Conventional Treatment

NCT04493398 | Completed

• 1 other identifier: 2016/793
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: To effectively disrupt microbial biofilm and remove dental calculus with minimal damage to the root surface and soft tissues with limited patient discomfort constitute a significant tenet of periodontal therapy. The aim of the present prospective 12-month study was to compare clinical and microbiological effects following an erythritol air-polishing vs. conventional mechanical debridement of furcation defects in a cohort of periodontal maintenance patients. Methods: Twenty patients with grade II mandibular molar furcation defects volunteered to enroll in this study. In a split-mouth design, two furcation sites in each patient were randomly assigned to either receive subgingival debridement using erythritol air-polishing (test) or conventional ultrasonic/curette debridement (control) at baseline, and at 3, 6, 9 and 12 months. Probing depth, clinical attachment level and bleeding on probing were recorded at 3-month intervals. Subgingival microbiological samples obtained at baseline, 6 and 12 months were analyzed using checkerboard DNA-DNA hybridization. Discomfort from treatment was scored at 12 months using a visual analogue scale.

Conditions

Periodontitis; Adult Periodontitis

Keywords

Furcation involvement; Periodontal maintenance

Outcome Measures

Primary Outcomes (2)

• In 20 patients with grade II mandibular molar furcation defects, probing depth (PD) will be measured.

  PD: The vertical distance from the gingival margin to the probable base of the pocket in mm.

  12 months.

• In 20 patients with grade II mandibular molar furcation defects clinical attachment level (CAL) will be measured.

  CAL: The vertical distance in mm from the cemento-enamel junction or the margin of a dental restoration to the probable base of the pocket.

  12 months.

Secondary Outcomes (3)

• Bleeding on probing (BoP).

  12 months.

• Gingival crevicular fluid (GCF).

  12 months.

• Visual analogue scale (VAS).

  12 months.

Study Arms (2)

Titanium curette and ultrasonic.

ACTIVE COMPARATOR

Debridement of mandibular furcations with conventional ultrasonic/curette (control).

Procedure: Gracey curette.; Procedure: Ultrasonic scaler.

Erythritol air-polishing.

EXPERIMENTAL

Treatment of mandibular furcations with erythritol powder/air-polishing system (test)

Procedure: Erythritol air-polishing.

Interventions

Gracey curette. PROCEDURE

Root planed was performed with curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).

Titanium curette and ultrasonic.

Ultrasonic scaler. PROCEDURE

Debridement was performed with an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®; Electro Medical System, Nyon, Switzerland).

Titanium curette and ultrasonic.

Erythritol air-polishing. PROCEDURE

Treatment was performed with a low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland ) applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS, Nyon, Switzerland).

Erythritol air-polishing.

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received supportive periodontal therapy (SPT) every 3-6 months for 2-3 years following periodontal therapy.
• Having bilateral non-mobile, fully erupted mandibular first, second or third molars with degree II furcation defects.
• PD≥4 mm with bleeding or pus on probing. -

You may not qualify if:

• Mobile mandibular molars, molars with clinical or radiographic evidence of supra-/subgingival calculus or apical pathology.
• Use of systemic antibiotics within 6 months or SPT within 3 months of study.
• Any current medical condition affecting periodontal treatment or use of the abrasive air-polishing device.
• Subjects with diabetes, cancer, HIV/aids, acute infections, disorders that may compromise wound healing, or pregnant women.

Sponsors & Collaborators

• University of Bergen: lead

Related Publications (45)

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MeSH Terms

Conditions

Periodontitis; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Knut N. Leknes, Professor

  Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two operators performed the clinical aspects of this study. Author TS, masked to treatment assignments, performed all clinical recordings and sampling, author IU performed all treatments. All analyses were performed by a statistician (SAL) who had not taken part in data collection or treatments.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, single-masked controlled trial (RCT). A split-mouth study design where each of the furcation in the lower jaw molars was randomized to the two specific treatments. Hence, each patient received both interventions randomly allocated to each side of the lower jaw.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 30, 2020
• Study Start: June 1, 2015
• Primary Completion: June 30, 2016
• Study Completion: December 1, 2018
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share