NCT04782921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

March 1, 2021

Last Update Submit

January 23, 2023

Conditions

Periodontitis ComplexXenograft Model

Outcome Measures

Primary Outcomes (1)

  • 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®).

    6 and 12 months

Secondary Outcomes (2)

  • Wound closure (WC)

    1 week

  • Tip of papillae

    6 and 12 months

Other Outcomes (1)

  • Probing pocket depth (PPD)

    6 and 12 months

Study Arms (2)

Gel 40

EXPERIMENTAL

Application of Gel 40

Device: Xenogenic bone graft material

Gen-Os

ACTIVE COMPARATOR

Application of Gen-Os

Device: Xenogenic bone graft material

Interventions

Xenogenic bone graft materialDEVICE

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.

Gel 40Gen-Os

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine

Ljubljana, 1000, Slovenia

Location

University Dental Clinic

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • Kobe T, Povsic K, Gaspersic R. Prehydrated collagenated cortico-cancellous heterologous bone gel and papillae tunneling for isolated intrabony defects: 12-month noninferiority trial. Clin Exp Dent Res. 2024 Feb;10(1):e853. doi: 10.1002/cre2.853.

    PMID: 38345463DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

March 3, 2020

Primary Completion

August 20, 2022

Study Completion

September 20, 2022

Last Updated

January 25, 2023

Record last verified: 2022-01

Locations

SL(2)