Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects

Not Applicable

Completed

• Conditions: Periodontitis Complex; Xenograft Model
• Interventions: Device: Xenogenic bone graft material

• Registration Number: NCT04782921
• Lead Sponsor: University of Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Status Verified: 2022-01
• Primary Completion: 2022-08-20
• Study Completion: 2022-09-20
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gel 40	Xenogenic bone graft material	Application of Gel 40
Gen-Os	Xenogenic bone graft material	Application of Gen-Os

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Faculty of Medicine; 🇸🇮 Ljubljana, Slovenia

University Dental Clinic; 🇸🇮 Ljubljana, Slovenia