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Completed

NCT Number: 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.

This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.

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Key information

Conditions

Furcation Defects Mouth Diseases Periodontal Disease Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

About this study

Using a split-mouth design, fifteen patients with bilateral class II and III furcation defects were treated with MIST (Test Group) or CST (Control Group). Furcation defects in both groups were filled with anorganic bovine bone (ABB) and enamel matrix derivative (EMD). Patient-centered outcomes including analyses of pain, discomfort, edema, hematoma, root hypersensitivity and daily activities interference were recorded using a Visual Analogue Scale seven days after surgeries. Clinical and radiographic parameters were assessed at baseline and 6 months postoperatively. Data were statistically analysed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(I) subjects with a diagnosis of periodontitis; (II) presence of one pair of contralateral mandibular molars with buccal / lingual furcation defects; (III) non-smokers; (IV) plaque index < 20%.

Exclusion criteria

(I) patients that presented systemic disease; (II) had taken antibiotics in the past 6 months prior to surgery; (III) pregnant women or lactating mothers; (IV) molars with periapical disease; (V) cervical restorations or prosthesis closer than 1 mm to fornix; (VI) lingual furcation defects presenting gingival recession (GR)

Treatment and study plan

Anorganic Bovine Bone

Device

used to improve periodontal regenerative procedures.

Other names: Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).

Enamel Matrix Derivative

Device

used to improve periodontal regenerative procedures.

Other names: Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).

Primary outcomes

  1. Horizontal clinical attachment level (HCAL)

    Time frame: baseline and 6 months after surgical procedure

    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.

Secondary outcomes

  1. Pain Scores on the Visual Analogue Scale

    Time frame: 7 days after surgery

  2. Discomfort Scores on the Visual Analogue Scale

    Time frame: 7 days after surgery

  3. Edema Scores on the Visual Analogue Scale

    Time frame: 7 days after surgery

  4. Hematoma Scores on the Visual Analogue Scale

    Time frame: 7 days after surgery

  5. Root Hypersensitivity Scores on the Visual Analogue Scale

    Time frame: 7 days after surgery

  6. Daily Activities Interference Scores on the Visual Analogue Scale

    Time frame: 7 days after surgery

  7. Vertical clinical attachment level (VCAL)

    Time frame: baseline and 6 months

    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.

  8. Probing pocket depth (PPD)

    Time frame: baseline and 6 months

    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures

  9. Gingival recession

    Time frame: baseline and 6 months

    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures

Other outcomes

  1. Digital subtraction radiography density gain

    Time frame: baseline and 6 months

    The radiographs were obtained with the paralleling technique employing an x-ray unit and a digital sensor . Customized radiographic holders for each patient . Digital subtraction radiographs (DSR) were performed using a specific software. All pairs of baseline and 6-month radiographs for each treated site were then subtracted.

    Standardized regions of interest (ROIs) were select for each subtracted digital image: (1) placed in the bone's most coronal and central aspect of the furcation defect; and (2) placed at a distant untreated site acting as a radiographic control. The ROIs were not superimposed on any portion of the tooth surface. A software (Image Tool for Windows, Version 3.0, USA) was used to assess radiographic density changes that occurred in ROIs.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2014
Registry last updated
Apr 2, 2014

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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