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PeriodontitisNCT02761668

Timing of Orthodontic Therapy and Regenerative Periodontal Surgery in Advanced Periodontitis Patients With Pathologic Tooth Migration

A study testing ParS+Ortho 4W and ParS+Ortho 6M in people with Periodontitis and Tooth Migration, run by University of Bonn at 2 sites in 2 countries.

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

Pathologic tooth migration (PTM) is a common complication of advanced periodontitis and often motivation for patients to seek orthodontic therapy. An interdisciplinary approach is required to control the periodontal infection, reconstruct the defects and realign the migrated teeth. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
ParS+Ortho 4W and ParS+Ortho 6M
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesin 2 countries
Study dates
Oct 2016to 22 Mar 2023
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Advanced periodontitis
  • Presence of intrabony defects at a minimum of 2 and a maximum of 7 adjacent teeth (positions 15-25 or 35-45) in either the maxilla or the mandible with PPD of ≥6 mm at a minimum on one site
  • Pathologic tooth migration
  • Full mouth plaque index (PI) <25% at baseline (after initial non-surgical periodontal therapy)
  • Full mouth bleeding on probing (FMBP) <25% at baseline (i.e., following initial non-surgical periodontal therapy)
  • Committed to the study and the required follow-up visits

Who cannot join

  • Any contraindications for oral surgical procedures
  • Uncontrolled diabetes or other uncontrolled systemic diseases
  • Disorders or treatments that compromise wound healing
  • Medical conditions requiring chronic high dose steroid therapy
  • Bone metabolic diseases
  • Radiation or other immuno-suppressive therapy
Show all 11Show fewer
  • Infections or vascular impairment at the surgical site
  • Presence of oral lesions (such as ulceration, malignancy) or mucosal diseases
  • History of malignant disease in the oral cavity or previous radiotherapy to the head
  • Inadequate oral hygiene or unmotivated for adequate home care
  • Current smokers > 6Cig

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde

    Bonn, North Rhine-Westphalia, 53111

Other trials in Germany

Spain1 site

  • Master de Periodoncia Universidad Complutense

    Madrid, 28040

Other trials in Spain

About this study

Official title: The Effect of Timing of Orthodontic Therapy on the Outcomes of Regenerative Periodontal Surgery in Patients With Advanced Periodontitis and Pathologic Tooth Migration. A Multi Centre Randomized Clinical Trial.

Pathologic tooth migration (PTM) is a common complication of advanced periodontitis and often motivation for patients to seek orthodontic therapy. An interdisciplinary approach is required to control the periodontal infection, reconstruct the defects and realign the migrated teeth. The optimal timing of active orthodontics after regenerative therapy is a topic of ongoing debate.

There are no data available from RCTs that have compared the effect of the timing of orthodontic tooth movement (early vs. late) on the outcomes of regenerative periodontal surgery in these patients.

Read more

It is the aim of the present randomized clinical multicenter trial to compare 2 different treatment protocols of a combined perio-regenerative and orthodontic therapy in advanced periodontitis patients with intrabony defects and pathologic tooth migration in order to establish whether one treatment modality is superior to the other with regard to clinical outcomes. A total of 46 patients will be enrolled and randomized into 2 treatment groups that differ by the time point of initiation of orthodontic therapy (early: 4 weeks vs. late: 6 months following regenerative periodontal surgery).

Primary outcome measure will be the change in clinical attachment level (CAL gain) at 12 months after regenerative therapy. Secondary outcomes will include changes in probing depth BOP, gingival recession, radiographic bone height and patient-centered outcomes.

Being tested
ParS+Ortho 4W, ParS+Ortho 6M
Keywords
Pathological tooth migration, periodontal regenerative surgery, vertical infrabony defects, xenogeneic bone graft, orthodontic therapy
Medical subject headings
Periodontitis, Tooth Migration

What participants receive

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

  • ParS+Ortho 4WProcedure or surgery

    Orthodontics 4 weeks post surgical

  • ParS+Ortho 6MProcedure or surgery

    Orthodontics 6 months post surgical

Study groups in NCT02761668
Study groupRoleWhat they receive
ParS+Ortho 4WExperimentalOrthodontic alignment starts 4 weeks post surgical
Receives: Procedure: ParS+Ortho 4W
ParS+Ortho 6MActive comparatorOrthodontic alignment starts 6 months post surgical
Receives: Procedure: ParS+Ortho 6M

What is being measured

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

  1. Clinical attachment level (CAL) at test site

    Clinical attachment level (CAL)measurements 12 months after surgery

    Measured: 12 months

Secondary outcomes (8)

  1. Probing depth (PD) at test site

    Probing depth (PD) )measurements 12 and 24 months after surgery

    Measured: 24 months

  2. Mean probing depth (PD)

    Mean probing depth (PD) )measurements 12 and 24 months after surgery

    Measured: 24 months

  3. Bleeding on Probing (BoP) at test site

    Bleeding on Probing (BoP) measurements 12 and 24 months after surgery

    Measured: 24 months

  4. Mean bleeding on Probing (BoP)

    Mean Bleeding on Probing (BoP) measurements 12 and 24 months after surgery

    Measured: 24 months

  5. Plaque (PI) at test site

    Plaque (PI) measurements 12 and 24 months after surgery

    Measured: 24 months

  6. Mean Plaque (PI)

    Plaque (PI) measurements 12 months after surgery

    Measured: 24 months

  7. Mean clinical attachment level (CAL)

    Mean clinical attachment level (CAL)12 months after surgery

    Measured: 24 months

  8. PROMS

    Patient reported Outcomes

    Measured: 24 months

Timeline

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

  1. First posted4 May 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion22 Jul 2020
  4. Study completion22 Mar 2023

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02761668
Sponsor's protocol ID
PARO/KFO-15-249
Status last verified
Mar 2023
First submitted
30 Apr 2016
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Lindhe J, Svanberg G. Influence of trauma from occlusion on progression of experimental periodontitis in the beagle dog. J Clin Periodontol. 1974;1(1):3-14. doi: 10.1111/j.1600-051x.1974.tb01234.x. No abstract available.

    PubMed 4532114

  • Ericsson I, Thilander B, Lindhe J, Okamoto H. The effect of orthodontic tilting movements on the periodontal tissues of infected and non-infected dentitions in dogs. J Clin Periodontol. 1977 Nov;4(4):278-93. doi: 10.1111/j.1600-051x.1977.tb01900.x. No abstract available.

    PubMed 271655

  • Re S, Corrente G, Abundo R, Cardaropoli D. Orthodontic treatment in periodontally compromised patients: 12-year report. Int J Periodontics Restorative Dent. 2000 Feb;20(1):31-9.

    PubMed 11203546

  • Ghezzi C, Masiero S, Silvestri M, Zanotti G, Rasperini G. Orthodontic treatment of periodontally involved teeth after tissue regeneration. Int J Periodontics Restorative Dent. 2008 Dec;28(6):559-67.

    PubMed 19146051

  • 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

  • Jepsen K, Jaeger A, Jepsen S. Esthetic and functional rehabilitation of a severely compromised central incisor: an interdisciplinary approach. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):e35-43. doi: 10.11607/prd.2345.

    PubMed 25909531

  • Ghezzi C, Viganò VM, Francinetti P, Zanotti G, Masiero S. Orthodontic treatment after induced periodontal regeneration in deep infrabony defects. Clinical Advances in Periodontics 2013; 3(1), 24-31

  • Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.

    PubMed 25867990

  • Tietmann C, Bröseler F, Axelrad T, Jepsen S. Regenerative procedures and orthodontics in the treatment of severe intrabony defects. A retrospective clinical cohort study. Int Poster J Dent Oral Med 2013; 15 Suppl. Poster 690.

  • Attia MS, Shoreibah EA, Ibrahim SA, Nassar HA. Regenerative therapy of osseous defects combined with orthodontic tooth movement. J Int Acad Periodontol. 2012 Jan;14(1):17-25.

    PubMed 22479985

  • 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

  • Brunsvold MA. Pathologic tooth migration. J Periodontol. 2005 Jun;76(6):859-66. doi: 10.1902/jop.2005.76.6.859.

    PubMed 15948679

  • Cardaropoli D, Gaveglio L, Abou-Arraj RV (2014). Orthodontic movement and periodontal defects: rationale, timing, and clinical implications. Semin Orthod, 20: 177-187.

  • Cortellini P, Stalpers G, Mollo A, Tonetti MS. Periodontal regeneration versus extraction and prosthetic replacement of teeth severely compromised by attachment loss to the apex: 5-year results of an ongoing randomized clinical trial. J Clin Periodontol. 2011 Oct;38(10):915-24. doi: 10.1111/j.1600-051X.2011.01768.x. Epub 2011 Jul 21.

    PubMed 21777268

  • Sanz M, Martin C (2015). Tooth movement in the periodontally compromised patient. In: Clinical periodontology and implant dentistry. Eds: Niklaus P. Lang, Jan Lindhe, pp1297-1324, Wiley

Questions about this trial

What is this clinical trial studying?

A study testing ParS+Ortho 4W and ParS+Ortho 6M in people with Periodontitis and Tooth Migration, run by University of Bonn at 2 sites in 2 countries.

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 11 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 30 Mar 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 Germany, Spain. 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 (CAL) at test site (time frame: 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 NCT02761668, which also lists 18 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 30 Mar 2023.

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