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NCT Number: NCT02761668

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

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.

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.

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Key information

Conditions

Periodontitis Intrabony Periodontal Defect Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Migration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde, Bonn, North Rhine-Westphalia, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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
  • 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

Treatment and study plan

ParS+Ortho 4W

Procedure

Orthodontics 4 weeks post surgical

ParS+Ortho 6M

Procedure

Orthodontics 6 months post surgical

Primary outcomes

  1. Clinical attachment level (CAL) at test site

    Time frame: 12 months

    Clinical attachment level (CAL)measurements 12 months after surgery

Secondary outcomes

  1. Probing depth (PD) at test site

    Time frame: 24 months

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

  2. Mean probing depth (PD)

    Time frame: 24 months

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

  3. Bleeding on Probing (BoP) at test site

    Time frame: 24 months

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

  4. Mean bleeding on Probing (BoP)

    Time frame: 24 months

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

  5. Plaque (PI) at test site

    Time frame: 24 months

    Plaque (PI) measurements 12 and 24 months after surgery

  6. Mean Plaque (PI)

    Time frame: 24 months

    Plaque (PI) measurements 12 months after surgery

  7. Mean clinical attachment level (CAL)

    Time frame: 24 months

    Mean clinical attachment level (CAL)12 months after surgery

  8. PROMS

    Time frame: 24 months

    Patient reported Outcomes

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Collaborators

  • Universidad Complutense de Madrid

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2020
Study completion
2023
First posted
May 4, 2016
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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