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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03354182
Other study ID # 2015/03AVR/167
Secondary ID
Status Completed
Phase N/A
First received October 19, 2017
Last updated November 30, 2017
Start date July 30, 2015
Est. completion date January 2, 2017

Study information

Verified date June 2017
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study was to perform a randomized controlled clinical study in order to compare the effects of a bovine derived xenograft (with 10% collagen) + a bioabsorbable membrane (control group, CG) vs a bovine derived xenograft (with 10% collagen) alone (test group, TG) on the surgical treatment of mandibular type II furcation defects.


Description:

The aim of the study was to perform a randomized controlled clinical study in order to compare the effects of a bovine derived xenograft (with 10% collagen) + a bioabsorbable membrane (control group, CG) vs a bovine derived xenograft (with 10% collagen) alone (test group, TG) on the surgical treatment of mandibular type II furcation defects. The patients all underwent the same surgical intervention with the only difference between the two groups being the use or not of a collagen membrane.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date January 2, 2017
Est. primary completion date January 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients diagnosed with chronic periodontitis

- Initial phase (oral hygiene instructions + full mouth scaling and root planing) performed at least eight weeks before inclusion

- Full-mouth plaque score ? 20% (at least eight weeks after initial phase and during the whole treatment)

- Clinical evidence of vestibular or lingual mandibular Class II furcation defects (? 3mm of horizontal probing depth)

- Presence of at least 2 mm of keratinized gingiva on the selected tooth surface facing the furcation

- Tooth vitality confirmed by clinical tests (cold testing)

Exclusion Criteria:

- Presence of any systemic disease

- Smokers

- Devitalized tooth or tooth presenting periapical or pulpar pathology (confirmed with a retro-alveolar radiograph)

- Allergies to any of the products used in the present study

- Pregnant or breastfeeding women

- History or current RX therapy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Open flap surgery
Elevation of a flap in order to access the treated furcation
Device:
Bio-oss collagen
Biomaterial for periodontal surgery
Bio-gide
Biomaterial for periodontal surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type Measure Description Time frame Safety issue
Primary Horizontal Probing Attachment Level PAL-H 6 months
See also
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Not yet recruiting NCT06116487 - MRI as Alternative to CBCT for the Assessment of Furcation Involvement in Molars
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Recruiting NCT03180658 - Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans N/A
Active, not recruiting NCT05259982 - Vital Root-resective Therapy in Furcation-involved Maxillary Molars N/A
Active, not recruiting NCT02132806 - Piezosurgery in the Treatment of Class II Furcation Involvement N/A
Completed NCT02102360 - Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial. Phase 4
Not yet recruiting NCT06270303 - Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects N/A
Completed NCT04842188 - Furcation Treatment With L-PRF and aPDT N/A