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The Flapless Approach in Periodontal Regeneration

Primary Purpose

Periodontitis, Adult, Intrabony Periodontal Defect

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Flapless with Enamel Matrix Derivatives (EMD)
Flapless without Enamel Matrix Derivatives (EMD)
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Adult

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosis of periodontitis stage III or IV;
  • presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy;
  • a full-mouth plaque score and full-mouth bleeding score <15% at the time of the experimental procedure;
  • signed informed consent.

Exclusion Criteria:

  • relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing;
  • consumption of drugs known to affect periodontal status;
  • pregnancy and lactation;
  • third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration;
  • heavy smokers >10 cigarettes per day.

Sites / Locations

  • CIR Dental SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flapless with Enamel Matrix Derivatives (EMD)

Flapless alone

Arm Description

Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD).

Closed non-surgical treatment of periodontal intrabony defects without any adjunct.

Outcomes

Primary Outcome Measures

Clinical attachment level change
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Secondary Outcome Measures

Radiographic bone level change
Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)
Probing pocket depth change
Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Full Information

First Posted
July 8, 2022
Last Updated
October 17, 2023
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT05456555
Brief Title
The Flapless Approach in Periodontal Regeneration
Official Title
The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult, Intrabony Periodontal Defect

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
Flapless with Enamel Matrix Derivatives (EMD)
Arm Type
Experimental
Arm Description
Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD).
Arm Title
Flapless alone
Arm Type
Active Comparator
Arm Description
Closed non-surgical treatment of periodontal intrabony defects without any adjunct.
Intervention Type
Procedure
Intervention Name(s)
Flapless with Enamel Matrix Derivatives (EMD)
Intervention Description
Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. In the test group, the roots will be conditioned with 24% ethylenediaminetetraacetic acid (EDTA) for 2 minutes. After rinsing with sterile saline, enamel matrix derivatives (EMD) will be applied on the dried root surface.
Intervention Type
Procedure
Intervention Name(s)
Flapless without Enamel Matrix Derivatives (EMD)
Intervention Description
Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. No adjunct will be administered.
Primary Outcome Measure Information:
Title
Clinical attachment level change
Description
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Radiographic bone level change
Description
Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)
Time Frame
12 months
Title
Probing pocket depth change
Description
Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosis of periodontitis stage III or IV; presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy; a full-mouth plaque score and full-mouth bleeding score <15% at the time of the experimental procedure; signed informed consent. Exclusion Criteria: relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing; consumption of drugs known to affect periodontal status; pregnancy and lactation; third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration; heavy smokers >10 cigarettes per day.
Facility Information:
Facility Name
CIR Dental School
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Aimetti, Prof.
Phone
00390116331541
Email
mario.aimetti@unito.it

12. IPD Sharing Statement

Plan to Share IPD
No

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The Flapless Approach in Periodontal Regeneration

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