Periodontal Furcation LesionsNCT07738705
Treatment of Mandibular Class II Furcation With Different Types of Biomaterials in Humans
A study testing Surgical procedure using different types of biomaterials in people with Periodontal Furcation Lesions, run by Lake Erie College of Osteopathic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Furcation Lesions
- What is being tested?
- Surgical procedure using different types of biomaterials
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to 26 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
LECOM School of Dental Medicine
Bradenton, Florida, 34211
About this study
Official title: Treatment of Mandibular Class II Furcation With Different Types of Biomaterials
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
- Being tested
- Surgical procedure using different types of biomaterials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedure using different types of biomaterialsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Allograft + Microderm | Active comparator | Compared the results of using allograft with a microderm membrane aiming to decrease or close the furcation lesion. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Surgical procedure using different types of biomaterials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
Improvement of the Gingival Phenotype
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start18 Apr 2025
- Primary completion21 Jul 2026
- Study completion26 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Furcation LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lake Erie College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Osteogenics Biomedical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738705
- Sponsor's protocol ID
- IRB 31-122
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Mandibular Class II Furcation With Different Types of Biomaterials
- ClinicalTrials.gov ID
- NCT07738705
- Acronym / sponsor ID
- IRB 31-122
- Conditions
- Periodontal Furcation Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Lake Erie College of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- Osteogenics Biomedical
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 26 Jul 2026 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Allograft + Microderm | Active comparator | Procedure: Surgical procedure using different types of biomaterialsCompared the results of using allograft with a microderm membrane aiming to decrease or close the furcation lesion. |
| Group 2 - Allograft + Collagen Membrane | Active comparator | Procedure: Surgical procedure using different types of biomaterialsCompared the results of using allograft with a collagen membrane aiming to decrease or close the furcation lesion. |
| Group 3 - NovaBone + Microderm | Active comparator | Procedure: Surgical procedure using different types of biomaterialsCompared the results of using NovaBone with a microderm membrane aiming to decrease or close the furcation lesion. |
| Group 4 - NovaBone + Collagen Membrane | Active comparator | Procedure: Surgical procedure using different types of biomaterialsCompared the results of using NovaBone with a collagen membrane aiming to decrease or close the furcation lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Stage I or Stage II periodontitis.
- Current smokers.
- Uncontrolled diabetes mellitus.
- Alcohol or substance use disorder.
- Chronic inflammatory diseases requiring continuous anti-inflammatory therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical procedure using different types of biomaterialsCompared the results of using different combinations of NovaBone and allograft with a microderm or collagen membranes aiming to decrease or close the furcation lesion. | Procedure or surgery | Group 1 - Allograft + Microderm, Group 2 - Allograft + Collagen Membrane, Group 3 - NovaBone + Microderm, Group 4 - NovaBone + Collagen Membrane |
Primary outcome
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).
1 secondary outcome
Improvement of the Gingival Phenotype
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical procedure using different types of biomaterials in people with Periodontal Furcation Lesions, run by Lake Erie College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal Bone Gain (HBG). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.