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Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects (PTT)

Primary Purpose

Periodontitis Complex, Xenograft Model

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Xenogenic bone graft material
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis Complex

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • periodontitis stage III/IV
  • at least one periodontal lesion with pocket probing depth > 5 mm, limited by 2 or more bone walls and intrabony component > 3 mm.
  • good oral hygiene with plaque index and sulcular bleeding index < 30%.
  • systemically healthy
  • smokers and non-smokers

Exclusion Criteria:

  • systemic diseases that contraindicate the treatment,
  • on medications that affects periodontal healing
  • pregnant or lactating women
  • one wall intrabony defects
  • defects that involve buccal and lingual side of the tooth
  • tooth with incorrect endodontic treatment or restoration

Sites / Locations

  • Faculty of Medicine
  • University Dental Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gel 40

Gen-Os

Arm Description

Application of Gel 40

Application of Gen-Os

Outcomes

Primary Outcome Measures

Clinical attachment level change (CALC)
To evaluate the clinical attachment level change (CALG) in reconstructive periodontal treatment of isolated intrabony defects, using papillae preservation techniques and different biomaterials (Gel 40®, Gen-Os®).

Secondary Outcome Measures

Wound closure (WC)
To determine if the early wound healing is dependent on the treatment choice.
Tip of papillae
To determine aesthetic result by measuring papillae tip position

Full Information

First Posted
March 1, 2021
Last Updated
January 23, 2023
Sponsor
University of Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT04782921
Brief Title
Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects
Acronym
PTT
Official Title
Clinical Outcomes of Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects - a Prospective, Double Blind, Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ljubljana

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
Papillae tunneling techniques (PTT) are a new approach toward regeneration of isolated intrabony defects. Compared to regular papillae preservation techniques, PTT rely on complete preservation of involved interdental papillae, providing optimal healing environment for periodontal wound. Surgical access is therefore gained either by vertical incision in vestibulum, or by short releasing incision on adjacent tooth. Interdental tissue is then carefully raised in a full thickness manner by tunneling instruments, root surface thoroughly cleaned by the ultrasound scaler or Gracey curettes and defect filled with the biomaterial of choice. While the success and aesthetic results of non-incised papillae techniques are well documented, no paper so far compared clinical results of papillae preservation techniques with different biomaterials. Therefore, the aim of our study is to compare gain of clinical attachment level (defined by sum of pocket probing depth and recession) to regular papillae preservation techniques, and to prove non-inferiority of Gel 40® (collagen matrix, loaded with micronized heterologous bone) to Gen-Os® (granulated cortico-cancellous heterologous bone mix). Secondary objectives include analysis of aesthetic parameters - differences in recession and tip of the papillae location before and after the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis Complex, Xenograft Model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gel 40
Arm Type
Experimental
Arm Description
Application of Gel 40
Arm Title
Gen-Os
Arm Type
Active Comparator
Arm Description
Application of Gen-Os
Intervention Type
Device
Intervention Name(s)
Xenogenic bone graft material
Intervention Description
After access to the periodontal defect via straight incision in vestibulum, at the mucogingival border or short releasing incision on adjacent tooth, Gel 40 (a mixture of collagen gel and xenogenic bone particles) or Gen-Os (pure xenogenic bone particles) will be inserted.
Primary Outcome Measure Information:
Title
Clinical attachment level change (CALC)
Description
To evaluate the clinical attachment level change (CALG) in reconstructive periodontal treatment of isolated intrabony defects, using papillae preservation techniques and different biomaterials (Gel 40®, Gen-Os®).
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Wound closure (WC)
Description
To determine if the early wound healing is dependent on the treatment choice.
Time Frame
1 week
Title
Tip of papillae
Description
To determine aesthetic result by measuring papillae tip position
Time Frame
6 and 12 months
Other Pre-specified Outcome Measures:
Title
Probing pocket depth (PPD)
Description
Measured with periodontal probe
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: periodontitis stage III/IV at least one periodontal lesion with pocket probing depth > 5 mm, limited by 2 or more bone walls and intrabony component > 3 mm. good oral hygiene with plaque index and sulcular bleeding index < 30%. systemically healthy smokers and non-smokers Exclusion Criteria: systemic diseases that contraindicate the treatment, on medications that affects periodontal healing pregnant or lactating women one wall intrabony defects defects that involve buccal and lingual side of the tooth tooth with incorrect endodontic treatment or restoration
Facility Information:
Facility Name
Faculty of Medicine
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
University Dental Clinic
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

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Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects

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