The Clinical Effect of Implant Placement With a Simultaneous Soft Tissue Allograft
NCT ID: NCT02139748
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28 participants
INTERVENTIONAL
2014-07-31
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Each patient will receive a diagnostic work-up including standardized radiographs (periapicals), study casts, clinical photographs, and a periodontal examination. Presurgical preparation will include detailed oral hygiene instructions. Baseline data will be collected at initial exam. Parameters measured will include: plaque index, gingival index, probing depth, keratinized tissue, bleeding on probing, adjacent tooth recession, radiographic examination, tissue esthetics, colors, contours, and clinical photographs will be taken at baseline, during surgery and post-op visits.
The treatment will be randomly assigned using a coin toss. The mentor will flip the coin. The surgical procedure will consist of the reflection of full thickness flaps to expose the buccal crest. A dental implant will be placed in the edentulous site. Any implant system will be acceptable since the objective of the study is to evaluate soft tissue thickness and contour, not the dental implant. Either one layer of ADM or one layer of ADM plus bovine-derived xenograft (BX) will be placed following implant placement on the buccal aspect of the implant. When one layer of ADM is used it will be placed on the buccal surface of the implant only. When one layer of ADM and BX are used the BX will be overlaid buccal to the implant, then covered by ADM. Thus the buccal surface will have either one layer of ADM or one layer of ADM with BX. The surgical procedures will be documented with clinical photographs. Records will be kept of healing every 2 weeks for the first 8 weeks, then at 4 months or 16 weeks. At the end of 16 weeks or 4 months, once the study is completed, post and crown procedure over the implant can be started.
To provide adequate room to establish emergence profile the implant platform should be 3 to 4 mm apical to the mid-facial gingival margin when a 2-stage dental implant system is used. This may require reduction of the osseous crest by scalloping the bone so that the mid-facial osseous crest is 3-4 mm apical to the mid-facial gingival margin. This may result in a sub-crestal position of the interproximal implant platform (measured as a negative number). The top of the implant will be even with the crestal bone. The implant used will be any dental implant. At the time of surgery the implant platform will be placed even with the mid-facial osseous crest if a two-stage implant is used.
All probing measurements will be taken using the University of North Carolina probe. One investigator who is unaware of group assignment will perform all baseline examinations and all follow-up examinations. He will be calibrated prior to study initiation to assure that evaluations are consistent. The surgeon will perform all surgical procedures and will know the group to which each participant has been assigned. Standardized periapical radiographs will be taken at implant placement and at the 4-month examinations.
All patients will be seen at 1-2, 3-4, 5-6 and 7-8, and 16 weeks and buccal, occlusal and lingual clinical photographs will be taken at each visit. Patients will take doxycycline hyclate 100 mg qd for two weeks, Vicodin ES q4-6h as needed for pain, and naproxen 375 mg q12h for one week for inflammation. At post-operative visits plaque removal, and oral hygiene instruction, as needed, will be performed along with clinical photographs and standardized radiographs as scheduled.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dental Implant & ADM
Dental implant placement plus simultaneous grafting use one layer of ADM.
Dental Implant & ADM
A dental implant will be placed and the buccal soft tissue will be grafted using an acellular dermal matrix allograft.
Dental Implant & ADM & bone xenograft
Dental implant placement plus simultaneous grafting use one layer of ADM with bovine xenograft.
Dental Implant & ADM
A dental implant will be placed and the buccal soft tissue will be grafted using an acellular dermal matrix allograft.
Dental Implant & ADM & bone xenograft
A dental implant will be placed along with a buccal acellular dermal matrix allograft which will cover a bone xenograft.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dental Implant & ADM
A dental implant will be placed and the buccal soft tissue will be grafted using an acellular dermal matrix allograft.
Dental Implant & ADM & bone xenograft
A dental implant will be placed along with a buccal acellular dermal matrix allograft which will cover a bone xenograft.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Healthy persons at least 18 years old.
3. Understands and has signed the informed consent.
Exclusion Criteria
2. Previous head and neck radiation.
3. Patients who have taken oral bisphosphonates for \> 3 years or any IV bisphosphonates.
4. Smokers (or other tobacco habits that might interfere with soft tissue healing).
5. Patients who need prophylactic antibiotics prior to dental procedures.
6. Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.
7. Chemotherapy in the previous 12 months.
8. Psychological problems that would interfere with treatment.
9. Patients unable or unwilling to sign the informed consent.
10. Pregnant subjects will be excluded due to risk of miscarriage.
1. Failure of patient to follow treatment protocol.
2. Failure of implant to osseointegrate.
3. Failure of the allograft to heal.
4. Unanticipated healing complications that will adversely affect treatment results.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Louisville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Henry Greenwell
DMD, MSD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ting-wei H Hsu, D.M.D
Role: STUDY_DIRECTOR
Co-investigator, University of Louisville
Henry Greenwell, D.M.D, M.S.D
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Bobby L Cockerham, DDS
Role: STUDY_DIRECTOR
Co-investigator University of Louisville
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Graduate Periodontics, University of Louisville School of Dentistry
Louisville, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14.0387
Identifier Type: -
Identifier Source: org_study_id