Periodontitis, AggressiveNCT03340012
Clinical and Radiographic Evaluation of Guided Tissue Regeneration With Radiation-sterilized Allogenic Bone Grafts or Xenogenic Grafts for the Treatment of Intrabony Defects in Aggressive Periodontitis
A study testing GTR + radiation-sterilize allogenic bone graft and GTR + xenogenic graft in people with Periodontitis, Aggressive, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The treatment of intrabony defects in patients with aggressive periodontitis remains a challenging procedure and novel therapeutic strategies are sought. The purpose of this study is to compare the clinical and radiographic outcomes of using guided tissue regeneration (GTR) with radiation-sterilized allogenic bone… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis, Aggressive
- What is being tested?
- GTR + radiation-sterilize allogenic bone graft and GTR + xenogenic graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jan 2018to 5 May 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of aggressive periodontitis in line with American Academy of Periodontology classification (Lang et al. 1999)
- Familial aggregation (history of periodontitis in parents or siblings)
- Presence of at least two teeth with probing pocket depth (PPD) ≥ 6mm and clinical attachment level (CAL) ≥ 5 mm associated with an intrabony defect of at least 3 mm as detected in diagnostic periapical radiographs
- No furcation involvement of the teeth presenting the intraosseous defects
- The width of keratinized tissue on the facial aspect of the selected teeth ≥ 2 mm
Who cannot join
- Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking more than 10 cigarettes/day
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
- Pregnant and lactating females
- Previous periodontal surgery in the area
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, Mazowsze, 00-246
Batlomiej Gorski, DDS, PhD, +48 22 502 20 99
About this study
Official title: Clinical and Radiographic Evaluation of Guided Tissue Regeneration With Radiation-sterilized Allogenic Bone Grafts or Xenogenic Grafts for the Treatment of Intrabony Defects in Aggressive Periodontitis: A Randomized Clinical Trial
The treatment of intrabony defects in patients with aggressive periodontitis remains a challenging procedure and novel therapeutic strategies are sought. The purpose of this study is to compare the clinical and radiographic outcomes of using guided tissue regeneration (GTR) with radiation-sterilized allogenic bone grafts (material prepared in the Central Tissue Bank in Warsaw, Poland) versus guided tissue regeneration with xenogenic grafts (Bio-Oss®, Geistlich Biomaterials, Princeton, New Jersey, United States) in the treatment of localized intrabony defects in patients with aggressive periodontitis.
- Conditions
- Periodontitis, Aggressive
- Being tested
- GTR + radiation-sterilize allogenic bone graft, GTR + xenogenic graft
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTR + radiation-sterilize allogenic bone graftDevice
Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and radiation-sterilized allogenic bone graft from the Central Tissue Bank in Warsaw
GTR + xenogenic graftDevice
Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and xenogenic graft (Bio-Oss®, Geistlich Biomaterials)
| Study group | Role | What they receive |
|---|---|---|
| GTR + radiation-sterilize allogenic bone graft (TEST) | Experimental | The surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of radiation-sterilized allogenic bone graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures. Receives: Device: GTR + radiation-sterilize allogenic bone graft |
| GTR + xenogenic graft (CONTROL) | Active comparator | The surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of xenogenic graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures. Receives: Device: GTR + xenogenic graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical attachment level (CAL)
CAL will be measured in millimeters on the study teeth at 6 locations as a distance from the cementoenamel junction to the bottom of the gingival sulcus. The average differences between 12 months and baseline measurements at the sites with the most advanced attachment loss at baseline will be compared.
Measured: Baseline and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start5 Jan 2018 (estimated)
- Primary completion5 May 2019 (estimated)
- Study completion5 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AggressiveStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340012
- Sponsor's protocol ID
- WUM.PERIO.02
- Status last verified
- Nov 2017
- First submitted
- 8 Nov 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Guided Tissue Regeneration With Radiation-sterilized Allogenic Bone Grafts or Xenogenic Grafts for the Treatment of Intrabony Defects in Aggressive Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03340012
- Acronym / sponsor ID
- WUM.PERIO.02
- Conditions
- Periodontitis, Aggressive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 5 Jan 2018 (estimated)
- Primary completion
- 5 May 2019 (estimated)
- Study completion
- 5 May 2019 (estimated)
- First posted
- 13 Nov 2017 (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.
The treatment of intrabony defects in patients with aggressive periodontitis remains a challenging procedure and novel therapeutic strategies are sought. The purpose of this study is to compare the clinical and radiographic outcomes of using guided tissue regeneration (GTR) with radiation-sterilized allogenic bone grafts (material prepared in the Central Tissue Bank in Warsaw, Poland) versus guided tissue regeneration with xenogenic grafts (Bio-Oss®, Geistlich Biomaterials, Princeton, New Jersey, United States) in the treatment of localized intrabony defects in patients with aggressive periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GTR + radiation-sterilize allogenic bone graft (TEST) | Experimental | Device: GTR + radiation-sterilize allogenic bone graftThe surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of radiation-sterilized allogenic bone graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures. |
| GTR + xenogenic graft (CONTROL) | Active comparator | Device: GTR + xenogenic graftThe surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of xenogenic graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of aggressive periodontitis in line with American Academy of Periodontology classification (Lang et al. 1999)
- Familial aggregation (history of periodontitis in parents or siblings)
- Presence of at least two teeth with probing pocket depth (PPD) ≥ 6mm and clinical attachment level (CAL) ≥ 5 mm associated with an intrabony defect of at least 3 mm as detected in diagnostic periapical radiographs
- No furcation involvement of the teeth presenting the intraosseous defects
- The width of keratinized tissue on the facial aspect of the selected teeth ≥ 2 mm
Key exclusion criteria (7 listed)
- Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking more than 10 cigarettes/day
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
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 |
|---|---|---|
| GTR + radiation-sterilize allogenic bone graftGuided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and radiation-sterilized allogenic bone graft from the Central Tissue Bank in Warsaw | Device | GTR + radiation-sterilize allogenic bone graft (TEST) |
| GTR + xenogenic graftGuided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and xenogenic graft (Bio-Oss®, Geistlich Biomaterials) | Device | GTR + xenogenic graft (CONTROL) |
Primary outcome
Change in Clinical attachment level (CAL)
Time frame: Baseline and 12 months after surgery
CAL will be measured in millimeters on the study teeth at 6 locations as a distance from the cementoenamel junction to the bottom of the gingival sulcus. The average differences between 12 months and baseline measurements at the sites with the most advanced attachment loss at baseline will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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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.
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTR + radiation-sterilize allogenic bone graft and GTR + xenogenic graft in people with Periodontitis, Aggressive, run by Medical University of Warsaw at 1 site in Poland.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical attachment level (CAL) (time frame: Baseline and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2017.