Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontitis Complex, Xenograft Model

Intervention / Treatment
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* Device: Xenogenic bone graft material


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gel 40<br>Application of Gel 40 | Device: Xenogenic bone graft material<br>* 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.<br>|
| Active Comparator: Gen-Os<br>Application of Gen-Os | Device: Xenogenic bone graft material<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound closure (WC) | To determine if the early wound healing is dependent on the treatment choice. | 1 week | 
| Tip of papillae | To determine aesthetic result by measuring papillae tip position | 6 and 12 months |