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

NCT07738705 | Completed

• 1 other identifier: IRB 31-122
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Furcation Lesions

Outcome Measures

Primary Outcomes (1)

• Horizontal Bone Gain (HBG).

  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).

  6 months

Secondary Outcomes (1)

• Improvement of the Gingival Phenotype

  6 months

Study Arms (4)

Group 1 - Allograft + Microderm

ACTIVE COMPARATOR

Compared the results of using allograft with a microderm membrane aiming to decrease or close the furcation lesion.

Procedure: Surgical procedure using different types of biomaterials

Group 2 - Allograft + Collagen Membrane

ACTIVE COMPARATOR

Compared the results of using allograft with a collagen membrane aiming to decrease or close the furcation lesion.

Procedure: Surgical procedure using different types of biomaterials

Group 3 - NovaBone + Microderm

ACTIVE COMPARATOR

Compared the results of using NovaBone with a microderm membrane aiming to decrease or close the furcation lesion.

Procedure: Surgical procedure using different types of biomaterials

Group 4 - NovaBone + Collagen Membrane

ACTIVE COMPARATOR

Compared the results of using NovaBone with a collagen membrane aiming to decrease or close the furcation lesion.

Procedure: Surgical procedure using different types of biomaterials

Interventions

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.

Group 1 - Allograft + Microderm; Group 2 - Allograft + Collagen Membrane; Group 3 - NovaBone + Microderm; Group 4 - NovaBone + Collagen Membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lake Erie College of Osteopathic Medicine: lead
• Osteogenics Biomedical: collaborator

Study Sites (1)

LECOM School of Dental Medicine

Bradenton, Florida, 34211, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 31, 2026
• Study Start: April 18, 2025
• Primary Completion: July 21, 2026
• Study Completion: July 26, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

US (1)