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

Sponsor

University of Bonn (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02761668

Collaborator

Universidad Complutense de Madrid (Other)

Enrollment

Locations

Arms

57.7

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Tooth Migration Intrabony Periodontal Defect	Procedure: ParS+Ortho 4W Procedure: ParS+Ortho 6M	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Jul 22, 2020

Anticipated Study Completion Date :

Jul 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ParS+Ortho 4W Orthodontic alignment starts 4 weeks post surgical	Procedure: ParS+Ortho 4W Orthodontics 4 weeks post surgical
Active Comparator: ParS+Ortho 6M Orthodontic alignment starts 6 months post surgical	Procedure: ParS+Ortho 6M Orthodontics 6 months post surgical

Arm

Intervention/Treatment

Experimental: ParS+Ortho 4W

Orthodontic alignment starts 4 weeks post surgical

Procedure: ParS+Ortho 4W

Orthodontics 4 weeks post surgical

Active Comparator: ParS+Ortho 6M

Orthodontic alignment starts 6 months post surgical

Procedure: ParS+Ortho 6M

Orthodontics 6 months post surgical

Outcome Measures

Primary Outcome Measures

Clinical attachment level (CAL) at test site [12 months]
Clinical attachment level (CAL)measurements 12 months after surgery

Secondary Outcome Measures

Probing depth (PD) at test site [12 months]
Probing depth (PD) )measurements 12 months after surgery
Mean probing depth (PD) [12 months]
Mean probing depth (PD) )measurements 12 months after surgery
Bleeding on Probing (BoP) at test site [12 months]
Bleeding on Probing (BoP) measurements 12 months after surgery
Mean bleeding on Probing (BoP) [12 months]
Mean Bleeding on Probing (BoP) measurements 12 months after surgery
Plaque (PI) at test site [12 months]
Plaque (PI) measurements 12 months after surgery
Mean Plaque (PI) [12 months]
Plaque (PI) measurements 12 months after surgery
Mean clinical attachment level (CAL) [12 months]
Mean clinical attachment level (CAL)12 months after surgery
PROMS [12 months]
Patient reported Outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poliklinik für Parodontologie, Zahnerhaltung und Präventive Zahnheilkunde	Bonn	North Rhine-Westphalia	Germany	53111
2	Master de Periodoncia Universidad Complutense	Madrid		Spain	28040