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Intrabony Periodontal DefectNCT04896450

Comparison of the GTR Procedure Alone and in Combination With Immediate OTM

A study testing Guided tissue regeneration (GTR) and Orthodontic tooth movement (OTM) in people with Intrabony Periodontal Defect, run by Semmelweis University at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of a GTR procedure, when it is combined with an immediate orthodontic tooth movement or used alone. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Intrabony Periodontal Defect
What is being tested?
Guided tissue regeneration (GTR) and Orthodontic tooth movement (OTM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteHungary
Study dates
Sep 2015to Dec 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Periodontitis with intrabony defect (Intrabony component ≥ 4mm, defect radiological angulation > 25°, 1 or max. 2 bony walls (no buccal bony wall), non-containing defect), no class III. furcation involved teeth
  • Selected tooth must be in a traumatic occlusion or not in a gnathologically correct bite (migrated, elongated, tilted tooth, etc.).
  • Patients must not be heavy smokers (<5 cigarettes/day).
  • Full mouth plaque and bleeding scores (FMPS and FMBS) of <20% (O'Leary et al. 1972).
  • The patient is able to comply with the study -related procedures (i.e. good level of oral hygiene, follow-up procedures).
  • The patient is able to fully understand the nature of the study, signed informed consent.

Who cannot join

  • Pregnant women.
  • Participation in another clinical study within 30 days prior to study start.
  • Alcoholism, drug dependency, heavy smoking (>5 cigarettes/day).
  • Known infection with HIV, HBV, or HCV.
  • Patients requiring chemo- or radiotherapy.
  • Previous or current radiotherapy of the head.
Show all 12Show fewer
  • Uncontrolled or insulin-dependent diabetes mellitus
  • Clinically relevant osteoporosis or systemic disease affecting bone metabolism
  • Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months.
  • Clinically relevant blood coagulation disorder.
  • Previous or current treatment with systemic corticosteroids (within 2 months prior to screening visit) of more than 5 mg/day prednisone equivalent.
  • Previous or current therapy with bisphosphonates at least for 30 days within the last 12 months before screening visit.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Semmelweis University Department of Periodontology

    Budapest, 1088

Other trials in Hungary

About this study

Official title: Comparison of the Guided Tissue Regeneration (GTR) Procedure Alone and in Combination With Immediate Orthodontic Tooth Movement (OTM) in the Treatment of Non-containing and Wide Intrabony Periodontal Defects: a Prospective RCT

The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of a GTR procedure, when it is combined with an immediate orthodontic tooth movement or used alone. Clinical, radiological and reentry (histological) evaluation of a regenerative surgical method (GTR + grafting material) with different postsurgical healing patterns in the treatment of wide, non-containing intrabony defects.

Read the detailed description

There is limited histological data in literature on the behavior of xenogeneic graft materials in intrabony defects used in periodontal regenerative therapy followed by orthodontic tooth movement (OTM). This clinical study aims to clinically and histologically evaluate the healing response of the periodontal tissues and the healing pattern of a non-resorbable graft material, when they are exposed to orthodontic forces. Therefore teeth presenting non-contained intrabony defects in combination with pathologic tooth migration (PTM) are included in this prospective clinical study. Guided tissue regeneration (GTR) with the application of deproteinized bovine bone mineral (DBBM) and a resorbable collagen membrane is utilized to surgically treat the periodontal defects, which is followed by a random allocation of the patients into test or control group. Subject teeth undergo an early initiated orthodontic treatment after surgery or stay splinted without any tooth movement in the latter groups, respectively. Teeth in test group can be further divided into subgroups, depending if they are moved toward to the former defect (pressure site) or moved away from the defect (tension site). After 9 months of healing a reentry surgery is performed, when a biopsy core is removed with a microtrephine from the previous defect site. The sample is evaluated by means of histology supplemented with histomorphometry, which is the primary outcome variable. Periodontal clinical parameters measured at baseline and at 9 months serves for secondary outcomes. Several studies confirmed the success of graft materials in such comprehensive treatment approaches clinically, but we lack the human histologically proved data, whether DBBM bone substitute can be used safely when the tooth is exposed to OTM. Our main question is how orthodontic induced bone remodelling interferes with these graft particles, can they heal the same or even better compared to control sites. Tissue response might be different also in the case of the two test subgroups.

Being tested
Guided tissue regeneration (GTR), Orthodontic tooth movement (OTM)
Keywords
guided tissue regeneration, orthodontic tooth movement, histology, bone remodeling, deproteinized bovine bone mineral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guided tissue regeneration (GTR)Procedure or surgery

    Also called Regenerative surgery of an intrabony periodontal defect

    GTR is handled with the utilization of a coronally advanced flap, followed by a thorough debridement of the denudated root surface and the intrabony component. Regenerative materials are resorbable collagen membrane (BioGide, Geistlich Phara AG, Wolhusen, Switzerland) and deproteinized bovine bone mineral (BioOss, Geistlich Phara AG), finally surgery is finished with multilayer suturing technique.

  • Orthodontic tooth movement (OTM)Device

    Also called Multibond fixed orthodontic appliance

    An early initialization of the tooth movement with the help of a multibond fixed orthodontic device utilizing low level of continuous orthodontic forces.

Study groups in NCT04896450
Study groupRoleWhat they receive
Test groupExperimentalTest subjects receive GTR and early initiation of OTM.
Receives: Procedure: Guided tissue regeneration (GTR); Device: Orthodontic tooth movement (OTM)
Control groupActive comparatorControl subjects receive only GTR.
Receives: Procedure: Guided tissue regeneration (GTR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of newly formed bone by means of histomorphometry

    The percentage of newly formed bone of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention

    Measured: 9 months postoperatively

  2. Amount of graft material by means of histomorphometry

    The percentage of graft material (BioOss, Geistlich Pharma AG, Wolhusen) of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention

    Measured: 9 months postoperatively

  3. Amount of connective tissue by means of histomorphometry

    The percentage of connective tissue of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention

    Measured: 9 months postoperatively

Secondary outcomes (6)

  1. CAL

    Clinical attachment level gain

    Measured: 9 months postoperatively

  2. PPD

    Pocket probing depth reduction

    Measured: 9 months postoperatively

  3. GR

    Change in gingival recession

    Measured: 9 months postoperatively

  4. Bone gain

    The absolute fill of the periodontal defect

    Measured: 9 months postoperatively

  5. Bone loss

    The change of the crestal bony wall

    Measured: 9 months postoperatively

  6. Intrabony fill

    The change of the intrabony component compared to the initial intrabony defect depth (in percentage)

    Measured: 9 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study startSep 2015
  3. Primary completionDec 2022
  4. Study completionDec 2022

Resources

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
Model description
Patients undergo GTR procedure, after they are randomly allocated either to test (with OTM) or control group (without OTM)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04896450
Sponsor's protocol ID
ORTHO-GTR
Status last verified
Feb 2023
First submitted
29 Apr 2021
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Araujo MG, Carmagnola D, Berglundh T, Thilander B, Lindhe J. Orthodontic movement in bone defects augmented with Bio-Oss. An experimental study in dogs. J Clin Periodontol. 2001 Jan;28(1):73-80. doi: 10.1034/j.1600-051x.2001.280111.x.

    PubMed 11142670

  • Zucchelli G, De Sanctis M. A novel approach to minimizing gingival recession in the treatment of vertical bony defects. J Periodontol. 2008 Mar;79(3):567-74. doi: 10.1902/jop.2008.070315.

    PubMed 18315442

  • Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003 Dec;8(1):227-65. doi: 10.1902/annals.2003.8.1.227.

    PubMed 14971256

  • Reichert C, Deschner J, Kasaj A, Jager A. Guided tissue regeneration and orthodontics. A review of the literature. J Orofac Orthop. 2009 Jan;70(1):6-19. doi: 10.1007/s00056-009-0814-1. Epub 2009 Feb 5. English, German.

    PubMed 19194672

  • Cardaropoli D, Re S, Manuzzi W, Gaveglio L, Cardaropoli G. Bio-Oss collagen and orthodontic movement for the treatment of infrabony defects in the esthetic zone. Int J Periodontics Restorative Dent. 2006 Dec;26(6):553-9.

    PubMed 17243328

Questions about this trial

What is this clinical trial studying?

A study testing Guided tissue regeneration (GTR) and Orthodontic tooth movement (OTM) in people with Intrabony Periodontal Defect, run by Semmelweis University at 1 site in Hungary.

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 6 inclusion and 12 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 21 Feb 2023. 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 Hungary. 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?

Amount of newly formed bone by means of histomorphometry (time frame: 9 months postoperatively). The study lists 3 primary outcomes in all. 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 NCT04896450, which also lists 5 linked publications.

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 21 Feb 2023.

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