Back to results"Re-instrumentation vs Flap Surgery"
Primary Purpose
Periodontal Pocket, Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Flap surgery
Non surgical re-instrumentation
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Pocket focused on measuring non-surgical periodontal therapy, re-instrumentation
Eligibility Criteria
Inclusion Criteria:
- Age ≥18aa
- Patients with periodontal disease
- Less than 20 cigarettes/day
- No systemic antibiotic therapy in the last 3 months
- At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
- Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth
- No previous periodontal surgery at the experimental tooth
Exclusion Criteria:
- Connective tissue diseases
- Diabetes
- Pregnancy or lactating
- Furcation involvement
- Crowned tooth
- Severe tooth mobility (class III)
- Radiographical horizontal bone resorption exceeding the 50% of the root
Sites / Locations
- University of FlorenceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non surgical re-instrumentation
Flap surgery
Arm Description
The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.
All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).
Outcomes
Primary Outcome Measures
PD change
change in periodontal probing depth (in mm)
PD change
change in periodontal probing depth (in mm)
PD change
change in periodontal probing depth (in mm)
Secondary Outcome Measures
CAL change
change in clinical attachment level (in mm)
CAL change
change in clinical attachment level (in mm)
CAL change
change in clinical attachment level (in mm)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05460988
Brief Title
"Re-instrumentation vs Flap Surgery"
Official Title
"Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
May 11, 2023 (Actual)
Study Completion Date
May 11, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florence
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.
The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket, Periodontitis
Keywords
non-surgical periodontal therapy, re-instrumentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non surgical re-instrumentation
Arm Type
Experimental
Arm Description
The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.
Arm Title
Flap surgery
Arm Type
Active Comparator
Arm Description
All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).
Intervention Type
Procedure
Intervention Name(s)
Flap surgery
Intervention Description
All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).
Intervention Type
Procedure
Intervention Name(s)
Non surgical re-instrumentation
Intervention Description
The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.
Primary Outcome Measure Information:
Title
PD change
Description
change in periodontal probing depth (in mm)
Time Frame
3 months after the procedure
Title
PD change
Description
change in periodontal probing depth (in mm)
Time Frame
6 months after the procedure
Title
PD change
Description
change in periodontal probing depth (in mm)
Time Frame
12 months after the procedure
Secondary Outcome Measure Information:
Title
CAL change
Description
change in clinical attachment level (in mm)
Time Frame
3 months after the procedure
Title
CAL change
Description
change in clinical attachment level (in mm)
Time Frame
6 months after the procedure
Title
CAL change
Description
change in clinical attachment level (in mm)
Time Frame
12 months after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18aa
Patients with periodontal disease
Less than 20 cigarettes/day
No systemic antibiotic therapy in the last 3 months
At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth
No previous periodontal surgery at the experimental tooth
Exclusion Criteria:
Connective tissue diseases
Diabetes
Pregnancy or lactating
Furcation involvement
Crowned tooth
Severe tooth mobility (class III)
Radiographical horizontal bone resorption exceeding the 50% of the root
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Barbato, Dr.
Phone
+39 3299457556
Email
luigi.barbato@unifi.it
Facility Information:
Facility Name
University of Florence
City
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Barbato, Dr.
Phone
+39 3299457556
Email
luigi.barbato@unifi.it
12. IPD Sharing Statement
Learn more about this trial
"Re-instrumentation vs Flap Surgery"
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