Periodontitis ComplexPTTNCT04782921
Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects
A study testing Xenogenic bone graft material in people with Periodontitis Complex and Xenograft Model, run by University of Ljubljana at 2 sites in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis Complex, Xenograft Model
- What is being tested?
- Xenogenic bone graft material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSlovenia
- Study dates
- 3 Mar 2020to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
Faculty of Medicine
Ljubljana, 1000
University Dental Clinic
Ljubljana, 1000
About this study
Official title: 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.
Read more
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.
- Conditions
- Periodontitis Complex, Xenograft Model
- Being tested
- Xenogenic bone graft material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenogenic bone graft materialDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gel 40 | Experimental | Application of Gel 40 Receives: Device: Xenogenic bone graft material |
| Gen-Os | Active comparator | Application of Gen-Os Receives: Device: Xenogenic bone graft material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®).
Measured: 6 and 12 months
Secondary outcomes (2)
Wound closure (WC)
To determine if the early wound healing is dependent on the treatment choice.
Measured: 1 week
Tip of papillae
To determine aesthetic result by measuring papillae tip position
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start3 Mar 2020
- Primary completion20 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontitis ComplexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782921
- Sponsor's protocol ID
- UKCLjubljana
- Acronym
- PTT
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kobe T, Povsic K, Gaspersic R. Prehydrated collagenated cortico-cancellous heterologous bone gel and papillae tunneling for isolated intrabony defects: 12-month noninferiority trial. Clin Exp Dent Res. 2024 Feb;10(1):e853. doi: 10.1002/cre2.853.
PubMed 38345463
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects - a Prospective, Double Blind, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04782921
- Acronym / sponsor ID
- PTT / UKCLjubljana
- Conditions
- Periodontitis Complex, Xenograft Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gel 40 | Experimental | Device: Xenogenic bone graft materialApplication of Gel 40 |
| Gen-Os | Active comparator | Device: Xenogenic bone graft materialApplication of Gen-Os |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenogenic bone graft materialAfter 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. | Device | Gel 40, Gen-Os |
Primary outcome
Clinical attachment level change (CALC)
Time frame: 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®).
2 secondary outcomes
Wound closure (WC)
Time frame: 1 week
Tip of papillae
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 38345463Kobe T, Povsic K, Gaspersic R. Prehydrated collagenated cortico-cancellous heterologous bone gel and papillae tunneling for isolated intrabony defects: 12-month noninferiority trial. Clin Exp Dent Res. 2024 Feb;10(1):e853. doi: 10.1002/cre2.853.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenogenic bone graft material in people with Periodontitis Complex and Xenograft Model, run by University of Ljubljana at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level change (CALC) (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.