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Completed

NCT Number: NCT04782921

Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Ljubljana, Slovenia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xenogenic bone graft material

Device

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 outcomes

  1. Clinical attachment level change (CALC)

    Time frame: 6 and 12 months

    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 outcomes

  1. Wound closure (WC)

    Time frame: 1 week

    To determine if the early wound healing is dependent on the treatment choice.

  2. Tip of papillae

    Time frame: 6 and 12 months

    To determine aesthetic result by measuring papillae tip position

Other outcomes

  1. Probing pocket depth (PPD)

    Time frame: 6 and 12 months

    Measured with periodontal probe

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Registry information

Official study title

Clinical Outcomes of Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects - a Prospective, Double Blind, Randomised Clinical Trial

Acronym: PTT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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