Peri-implant Alveolar Bone ThicknessNCT01245920
Effects of Bone Graft Placement at Implant Installation on Buccal Plate Stability
A study testing DFDBA + Bio-Gide Membrane and Non-FDBA in people with Peri-implant Alveolar Bone Thickness, run by Creighton University at 1 site in United States.
Trial summary
This randomized clinical trial will involve at least 25 patients who have selected to receive a dental implant to replace a missing tooth. One group will receive the test treatment of a bone graft and a dissolvable membrane at the outer surface of the dental, while the control group will not receive the bone graft and… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Alveolar Bone Thickness
- What is being tested?
- DFDBA + Bio-Gide Membrane and Non-FDBA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to May 2012
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects willing and able to follow study procedures.
- Subjects treatment plan includes the placement of at least one endosseous dental implant in the maxillary or mandibular arch.
- Subjects must present with at least 1 mm buccal bone thickness immediately after surgical placement of endosseous dental implant.
- Subjects must demonstrate a plaque index of ≤20%.
- Subjects who can read, understand, and sign an institutional review board approved informed consent.
Who cannot join
- Subjects with systemic condition including diabetes mellitus, cancer, human immunodeficiency virus, or bone metabolic disease.
- Subjects who take corticosteroids, immunosuppressant, bisphosphonates, radiation treatments, and/or chemotherapeutics that could compromise wound healing process.
- Subjects with acute infectious lesions in the area of study.
- Subjects under 21 years of age.
- Subjects with previous failed endosseous dental implant at the site of study.
- Smokers.
- Subjects with dehiscence of implant surface > 1 mm immediately after surgical placement of endosseous dental implant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University School of Dentistry
Omaha, Nebraska, 68178
About this study
Official title: Effects of Bone Graft Placement at Implant Installation on Buccal Plate Stability: A Randomized Controlled Clinical Trial
This randomized clinical trial will involve at least 25 patients who have selected to receive a dental implant to replace a missing tooth. One group will receive the test treatment of a bone graft and a dissolvable membrane at the outer surface of the dental, while the control group will not receive the bone graft and membrane adjacent to the implant.
The following will be measured: bone thickness and height adjacent to implant, inflammation of gum tissue, recession of gum tissue, bleeding, pocket depth, and implant success. Patients will be followed for 1 year, including evaluation time points at 2 weeks, 1 month, 3 and 6 months, and 1 year. Statistical analysis of the data will be conducted.
The hypothesis is that there is no difference with regard to bone thickness, bone height, pocket depth, bleeding, and implant success rate for grafted implant sites compared to non-grafted implant sites.
Read the detailed description
Our study will include 25 patients. All patients will receive a comprehensive oral evaluation and periodontal examination prior to entry to this study. Patients will be selected on the basis of meeting the inclusion criteria, whose treatment plan is to receive an endosseous dental implant. They will be given oral hygiene instruction at each follow-up appointment. All test and control materials will be strictly controlled by the principal investigator who will maintain all study and patient information in a locked cabinet in a locked room to ensure patient privacy.
Primary Intervention:
Surgical Procedures:
Patients will rinse with 0.12% chlorhexidine gluconate for 60 s before the surgery, and 2 g amoxicillin or 600 mg clindamycin (if allergic to penicillin) will be administered. Sulcular and crestal incisions will be placed in the area of the planned implant. A full-thickness mucoperiosteal flap will be reflected. Surgical placement of an endosseous dental implant (Prima Implant System, Keystone Dental) will be carried out according to manufacturer's recommendation with the use of a surgical template. Following preparation of the osteotomy site to receive the implant, the thickness of the residual buccal bone will be measured and recorded to the nearest 0.5 mm, at approximately 0.5 mm apical to the crest with a caliper. After placement of the implant, the distance between the bony crest and the top of the implant will be measured and recorded to the nearest 1 mm for the buccal aspect of each implant with a periodontal probe (UNC-15). Titanium cover screws will be attached to the implants.
If the patient meets the inclusion criteria (buccal plate thickness is ≥1 mm), the treatment will be selected randomly through a coin toss. Heads indicates the subject will be entered in the FDBA + membrane group. Tails indicates the subject will be entered in the control group (non-FDBA).
Periosteal releasing incisions will be made to adequately mobilize the full-thickness mucoperiosteal flap. For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure. Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique. A post-operative periapical radiograph will be exposed of the implant.
Post-operative care will include oral administration of 500 mg amoxicillin 3 times daily for 7 days or 300 mg clindamycin 3 times daily for 7 days. Ibuprofen 600 mg every 8 h for 5 days will be prescribed for analgesics. Patients will be instructed to rinse with 0.12% chlorhexidine gluconate (Peridex, Zila Inc. Pheonix, AZ) twice daily for 1 month. Sutures will be removed 2 weeks post-surgery. Post-surgical evaluations will be provided at 2 weeks, 1 month, 3, and 6 months.
Stage II surgery will be performed 6 months after implant placement using the same flap design as the implant placement surgery. The titanium cover screw will be removed, and replaced with a titanium healing abutment. The distance from the bony crest to the top of the implant will be measured using the same technique described at the implant placement surgery. The buccal bone thickness will be measured by recording the distance from the buccal implant surface to the outer buccal bone crest to the nearest 1 mm using a periodontal probe (UNC-15). Photos of the study site will be taken at each surgical procedure and at each follow-up appointment.
Post-Surgical Clinical Measurements:
The following clinical measurements will be obtained with a plastic periodontal probe at 6 sites at each implant (Colorview, Hu-Friedy, Chicago, IL) and recorded to the nearest millimeter: probing depth, gingival margin position, bleeding on probing, and gingival index. The gingival index will be assessed according to Silness and Loe on a scale of 0-3. Implant mobility will also be assessed using an instrument handle and a finger. The soft tissue clinical measurements will be obtained at the following time periods: 1 month following Stage II surgery and 6 months following Stage II surgery (1 year after implant placement). Final implant abutments and crowns will proceed according to the original treatment plan of the patient.
- Conditions
- Peri-implant Alveolar Bone Thickness
- Being tested
- DFDBA + Bio-Gide Membrane, Non-FDBA
- Keywords
- Dental implant, Alveolar bone, Clinical attachment Level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFDBA + Bio-Gide MembraneBiological
Also called Puros bone allograft, Bio-Gide membrane
For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure.
Non-FDBAOther
Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique.
| Study group | Role | What they receive |
|---|---|---|
| FDBA + Membrane Group | Experimental | For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure. Receives: Biological: DFDBA + Bio-Gide Membrane |
| Non-FDBA | Active comparator | Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique. Receives: Other: Non-FDBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Buccal Bone Thickness
The buccal bone thickness will be measured by recording the distance from the buccal implant surface to the outer buccal bone crest to the nearest 1 mm using a periodontal probe (UNC-15).
Measured: 6 months
Secondary outcomes (1)
Change in Clinical Attachment Level
The following clinical measurements will be obtained with a plastic periodontal probe at 6 sites at each implant (Colorview, Hu-Friedy, Chicago, IL) and recorded to the nearest millimeter: probing depth and gingival margin position
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012
Why it stopped: Inadequate number of patients whou could meet inclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Alveolar Bone ThicknessStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Nebraska Society of Periodontology
- Investigators
- Melissa S Lang, DDS, MS, Principal investigator, Creighton University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245920
- Sponsor's protocol ID
- 10-15770
- Status last verified
- Aug 2012
- First submitted
- 19 Nov 2010
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bone Graft Placement at Implant Installation on Buccal Plate Stability: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01245920
- Acronym / sponsor ID
- 10-15770
- Conditions
- Peri-implant Alveolar Bone Thickness
- Keywords
- Dental implant, Alveolar bone, Clinical attachment Level
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate number of patients whou could meet inclusion criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Nebraska Society of Periodontology
- Study start
- Nov 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (actual)
- First posted
- 23 Nov 2010 (estimated)
- 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 clinical trial will involve at least 25 patients who have selected to receive a dental implant to replace a missing tooth. One group will receive the test treatment of a bone graft and a dissolvable membrane at the outer surface of the dental, while the control group will not receive the bone graft and membrane adjacent to the implant.
The following will be measured: bone thickness and height adjacent to implant, inflammation of gum tissue, recession of gum tissue, bleeding, pocket depth, and implant success. Patients will be followed for 1 year, including evaluation time points at 2 weeks, 1 month, 3 and 6 months, and 1 year. Statistical analysis of the data will be conducted.
The hypothesis is that there is no difference with regard to bone thickness, bone height, pocket depth, bleeding, and implant success rate for grafted implant sites compared to non-grafted implant sites.
Detailed description
Our study will include 25 patients. All patients will receive a comprehensive oral evaluation and periodontal examination prior to entry to this study. Patients will be selected on the basis of meeting the inclusion criteria, whose treatment plan is to receive an endosseous dental implant. They will be given oral hygiene instruction at each follow-up appointment. All test and control materials will be strictly controlled by the principal investigator who will maintain all study and patient information in a locked cabinet in a locked room to ensure patient privacy.
Primary Intervention:
Surgical Procedures:
Patients will rinse with 0.12% chlorhexidine gluconate for 60 s before the surgery, and 2 g amoxicillin or 600 mg clindamycin (if allergic to penicillin) will be administered. Sulcular and crestal incisions will be placed in the area of the planned implant. A full-thickness mucoperiosteal flap will be reflected. Surgical placement of an endosseous dental implant (Prima Implant System, Keystone Dental) will be carried out according to manufacturer's recommendation with the use of a surgical template. Following preparation of the osteotomy site to receive the implant, the thickness of the residual buccal bone will be measured and recorded to the nearest 0.5 mm, at approximately 0.5 mm apical to the crest with a caliper. After placement of the implant, the distance between the bony crest and the top of the implant will be measured and recorded to the nearest 1 mm for the buccal aspect of each implant with a periodontal probe (UNC-15). Titanium cover screws will be attached to the implants.
If the patient meets the inclusion criteria (buccal plate thickness is ≥1 mm), the treatment will be selected randomly through a coin toss. Heads indicates the subject will be entered in the FDBA + membrane group. Tails indicates the subject will be entered in the control group (non-FDBA).
Periosteal releasing incisions will be made to adequately mobilize the full-thickness mucoperiosteal flap. For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure. Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique. A post-operative periapical radiograph will be exposed of the implant.
Post-operative care will include oral administration of 500 mg amoxicillin 3 times daily for 7 days or 300 mg clindamycin 3 times daily for 7 days. Ibuprofen 600 mg every 8 h for 5 days will be prescribed for analgesics. Patients will be instructed to rinse with 0.12% chlorhexidine gluconate (Peridex, Zila Inc. Pheonix, AZ) twice daily for 1 month. Sutures will be removed 2 weeks post-surgery. Post-surgical evaluations will be provided at 2 weeks, 1 month, 3, and 6 months.
Stage II surgery will be performed 6 months after implant placement using the same flap design as the implant placement surgery. The titanium cover screw will be removed, and replaced with a titanium healing abutment. The distance from the bony crest to the top of the implant will be measured using the same technique described at the implant placement surgery. The buccal bone thickness will be measured by recording the distance from the buccal implant surface to the outer buccal bone crest to the nearest 1 mm using a periodontal probe (UNC-15). Photos of the study site will be taken at each surgical procedure and at each follow-up appointment.
Post-Surgical Clinical Measurements:
The following clinical measurements will be obtained with a plastic periodontal probe at 6 sites at each implant (Colorview, Hu-Friedy, Chicago, IL) and recorded to the nearest millimeter: probing depth, gingival margin position, bleeding on probing, and gingival index. The gingival index will be assessed according to Silness and Loe on a scale of 0-3. Implant mobility will also be assessed using an instrument handle and a finger. The soft tissue clinical measurements will be obtained at the following time periods: 1 month following Stage II surgery and 6 months following Stage II surgery (1 year after implant placement). Final implant abutments and crowns will proceed according to the original treatment plan of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDBA + Membrane Group | Experimental | Biological: DFDBA + Bio-Gide MembraneFor patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure. |
| Non-FDBA | Active comparator | Other: Non-FDBAPatients in the non-FDBA group will have gingival flaps closed with the same suturing technique. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects willing and able to follow study procedures.
- Subjects treatment plan includes the placement of at least one endosseous dental implant in the maxillary or mandibular arch.
- Subjects must present with at least 1 mm buccal bone thickness immediately after surgical placement of endosseous dental implant.
- Subjects must demonstrate a plaque index of ≤20%.
- Subjects who can read, understand, and sign an institutional review board approved informed consent.
Key exclusion criteria (7 listed)
- Subjects with systemic condition including diabetes mellitus, cancer, human immunodeficiency virus, or bone metabolic disease.
- Subjects who take corticosteroids, immunosuppressant, bisphosphonates, radiation treatments, and/or chemotherapeutics that could compromise wound healing process.
- Subjects with acute infectious lesions in the area of study.
- Subjects under 21 years of age.
- Subjects with previous failed endosseous dental implant at the site of study.
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 |
|---|---|---|
| DFDBA + Bio-Gide MembraneAlso: Puros bone allograft, Bio-Gide membraneFor patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure. | Biological | FDBA + Membrane Group |
| Non-FDBAPatients in the non-FDBA group will have gingival flaps closed with the same suturing technique. | Other | Non-FDBA |
Primary outcome
Change in Buccal Bone Thickness
Time frame: 6 months
The buccal bone thickness will be measured by recording the distance from the buccal implant surface to the outer buccal bone crest to the nearest 1 mm using a periodontal probe (UNC-15).
1 secondary outcome
Change in Clinical Attachment Level
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
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.
Melissa S Lang, DDS, MS principal investigator
Creighton University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DFDBA + Bio-Gide Membrane and Non-FDBA in people with Peri-implant Alveolar Bone Thickness, run by Creighton University 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Aug 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Buccal Bone Thickness (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 30 Aug 2012.