Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects

Xenograft Model Clinical Trial

— PTT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782921
• Other study ID #: UKCLjubljana
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: September 20, 2022

Study information

• Verified date: January 2022
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis
• Periodontitis Complex
• Xenograft Model

Intervention

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.

Locations

Country	Name	City	State
Slovenia	Faculty of Medicine	Ljubljana
Slovenia	University Dental Clinic	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Probing pocket depth (PPD)	Measured with periodontal probe	6 and 12 months
Primary	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	Wound closure (WC)	To determine if the early wound healing is dependent on the treatment choice.	1 week
Secondary	Tip of papillae	To determine aesthetic result by measuring papillae tip position	6 and 12 months