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Does a gentler root-cleaning method using air-polishing (Guided Biofilm Therapy) work as well as conventional instruments during periodontal surgery?

Clinical Outcomes with a Modified Surgical Technique Using Guided Biofilm Therapy (GBT®) Protocol in Step 3 of Periodontal Therapy: a Randomized Controlled Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16318269
Enrollment
34
Registered
2026-06-11
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III-IV periodontitis with residual periodontal pockets persisting after non-surgical (Step 2) periodontal therapy Oral Health

Interventions

Two-arm parallel RCT. Both arms receive Modified Widman Flap surgery under local anaesthesia (articaine 4% with epinephrine 1:100,000) with pre-surgical supragingival air-polishing, surgical loupes or
however, the single calibrated examiner who performs all clinical measurements and the statistician (groups coded A and B) are both blinded to allocation. TEST ARM: Root surface decontamination usin
AIR-FLOW PLUS erythritol powder 14 um) as primary debridement under direct vision, with biofilm disclosure, and conservative use of PIEZON PS tip and Gracey curettes only for residual visible calculus

Sponsors

Victor Babe? University of Medicine and Pharmacy Timi?oara
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Diagnosis of periodontitis stage III-IV according to the 2018 EFP/AAP classification 3. Completion of Step 2 periodontal therapy at least 6 weeks prior to inclusion 4. Between 4 and 6 teeth per quadrant with residual probing depth >=6 mm, presenting predominantly horizontal bone loss (<=2 mm intrabony component), confirmed radiographically and verified intra-surgically 5. Minimum 2 mm of keratinized tissue on all teeth in the operated quadrant 6. Full-mouth plaque score (FMPS) <=25% 7. Ability and willingness to provide written informed consent and to attend all study visits

Exclusion criteria

Exclusion criteria: 1. Systemic conditions known to affect periodontium (e.g. uncontrolled diabetes mellitus, immunosuppressive therapy, metabolic bone disease) 2. Known allergy or hypersensitivity to erythritol or any component of the air-polishing powder 3. Currently smoking more than 10 cigarettes per day 4. Pregnancy or breastfeeding 5. Periodontal surgery at the experimental sites within the previous 12 months 6. Furcation involvement requiring regenerative procedures, or any grade III furcation involvement 7. Tooth mobility greater than Miller class II 8. Clinical or radiographic signs of vertical or horizontal tooth fracture or active occlusal trauma 9. Inability to comply with the study protocol or to provide informed consent

Countries

Romania

Contacts

Public ContactSalvatore Chinnici
salvatore.chinnici@umft.ro+393275805994

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 29, 2026