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Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects

NCT04782921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-25

No results posted yet for this study

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.

Conditions

  • Periodontitis Complex
  • Xenograft Model

Interventions

DEVICE

Xenogenic bone graft material

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.

Sponsors & Collaborators

  • University of Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2022-08-20
Completion
2022-09-20

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04782921 on ClinicalTrials.gov