Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects (PTT)

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

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.

Study Overview

• Status: Completed
• Conditions: Xenograft Model; Periodontitis Complex
• Intervention / Treatment: Device: Xenogenic bone graft material

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Faculty of medicine
  • Ljubljana, Slovenia, 1000
    • University Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gel 40; Application of Gel 40	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.
Active Comparator: Gen-Os; Application of Gen-Os	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth (PPD)	Measured with periodontal probe	6 and 12 months

Collaborators and Investigators

• Sponsor: University of Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): August 20, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: UKCLjubljana

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No