Periodontitis Complex, Xenograft Model
Conditions
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.
Interventions
DEVICEXenogenic 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
University of Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level change (CALC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Wound closure (WC) | 1 week | To determine if the early wound healing is dependent on the treatment choice. |
| Tip of papillae | 6 and 12 months | To determine aesthetic result by measuring papillae tip position |
Other
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth (PPD) | 6 and 12 months | Measured with periodontal probe |
Countries
Slovenia
Outcome results
None listed