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OpenTrials
Completed

NCT Number: NCT07738705

Treatment of Mandibular Class II Furcation With Different Types of Biomaterials in Humans

This randomized controlled clinical trial aims to determine which biomaterial combination yields superior clinical and tomographic outcomes in the treatment of mandibular class II furcation defects. In addition, modifications of gingival phenotype in the furcation area will be assessed.

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Key information

Conditions

Periodontal Furcation Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LECOM School of Dental Medicine

Bradenton, Florida, 34211, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults diagnosed with Stage III or Stage IV periodontitis presenting with at least one mandibular molar with a Class II furcation defect requiring regenerative surgical treatment.
  • Ability and willingness to provide written informed consent.
  • Medically stable and able to undergo periodontal surgery.
  • Willingness to comply with all study procedures and follow-up visits.

Exclusion criteria

  • Stage I or Stage II periodontitis.
  • Current smokers.
  • Uncontrolled diabetes mellitus.
  • Alcohol or substance use disorder.
  • Chronic inflammatory diseases requiring continuous anti-inflammatory therapy.
  • Current use of bisphosphonates or other medications associated with medication-related osteonecrosis of the jaw.
  • Current use of medications known to induce gingival enlargement.
  • Continuous use of systemic antibiotics or anti-inflammatory medications.
  • Pregnant or breastfeeding individuals.
  • Known allergy or hypersensitivity to the antibiotics, local anesthetics, or other study-related medications.
  • Medical conditions that, in the investigator's judgment, make the participant unsuitable for periodontal surgery or study participation.

Treatment and study plan

Surgical procedure using different types of biomaterials

Procedure

Compared the results of using different combinations of NovaBone and allograft with a microderm or collagen membranes aiming to decrease or close the furcation lesion.

Primary outcomes

  1. Horizontal Bone Gain (HBG).

    Time frame: 6 months

    Cone-beam computed tomography (CBCT) measurements will be obtained at baseline and 6 months from the buccal or lingual bone edge to the deepest bone defect, measured horizontally. Sites will be classified as buccal or lingual and analyzed at the site level, first pooled and then separately. Change scores (6 months-baseline) will be assessed using the Shapiro-Wilk test. Within-group changes will be analyzed with paired t-tests or Wilcoxon signed-rank tests, as appropriate. Between-group comparisons of baseline values and 6-month changes will be performed using one-way ANOVA with Tukey's HSD or Kruskal-Wallis with Dunn's test (Holm adjustment). To account for multiple sites per participant, primary bone outcomes will be analyzed using linear mixed-effects models or generalized estimating equations when required. Statistical significance will be set at P<0.05. Analyses will be performed in Python 3 (pandas, SciPy, statsmodels).

Secondary outcomes

  1. Improvement of the Gingival Phenotype

    Time frame: 6 months

    Measurements will be obtained at baseline and 6 months using combined cone-beam computed tomography (CBCT) and oral scan images to determine gingival tissue width 2 mm apical to the gingival margin. Sites will be classified as buccal or lingual and analyzed at the site level, first pooled and then separately. Change scores (6 months-baseline) will be assessed using the Shapiro-Wilk test. Within-group changes will be analyzed with paired t-tests or Wilcoxon signed-rank tests, as appropriate. Between-group comparisons of baseline values and 6-month changes will be performed using one-way ANOVA with Tukey's HSD or Kruskal-Wallis with Dunn's test (Holm adjustment). To account for multiple sites per participant, outcomes will be analyzed using linear mixed-effects models or generalized estimating equations when required. Statistical significance will be set at P<0.05. Analyses will be performed in Python 3 (pandas, SciPy, statsmodels).

Sponsors and collaborators

Lead sponsor

Lake Erie College of Osteopathic Medicine

Other

Collaborators

  • Osteogenics Biomedical

Registry information

Official study title

Treatment of Mandibular Class II Furcation With Different Types of Biomaterials

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

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.