Vertical Soft Tissue Augmentation With CTG vs ADM
Launched by HARVARD MEDICAL SCHOOL (HMS AND HSDM) · Feb 6, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is comparing two different methods for improving the soft tissue around dental implants that have experienced complications. Specifically, it looks at using a patient's own connective tissue graft versus a type of tissue called acellular dermal matrix combined with an enamel matrix derivative. The goal is to see which approach works better in helping to heal and support the area around the implant.
To be eligible to join this study, participants must be at least 18 years old and generally healthy, with a dental implant in the front of their mouth that is functioning properly. Participants should not have conditions that could hinder healing, like uncontrolled diabetes or active infections, and should not be pregnant. If you’re interested in participating, you can expect to receive one of the two treatments and will be monitored throughout the process to assess the results. This trial is currently looking for volunteers of all genders between the ages of 18 and 75.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • Age ≥ 18 years
- • Periodontally and systemically healthy
- • Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
- • Presence of single functional dental implant in the anterior with a PSTD
- • Implants diagnosed as healthy (Berglundh et al., 2018)
- Exclusion criteria are:
- • Contraindications for surgery
- • Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing
- • Patients pregnant or attempting to get pregnant (self-reported)
- • Untreated periodontitis
- • Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018)
- • Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded
- • History of soft tissue grafting at the implant site within the last 6 months
About Harvard Medical School (Hms And Hsdm)
Harvard Medical School (HMS) and Harvard School of Dental Medicine (HSDM) are prestigious institutions renowned for their commitment to advancing medical and dental research, education, and patient care. As clinical trial sponsors, HMS and HSDM leverage their robust academic resources, cutting-edge laboratories, and a collaborative network of healthcare professionals to conduct innovative research that addresses critical health challenges. With a focus on translating scientific discoveries into clinical applications, these institutions foster an environment that promotes ethical research practices and prioritizes participant safety, ensuring that their clinical trials contribute significantly to the field of medicine and the well-being of communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Patients applied
Trial Officials
Lorenzo Tavelli, DDS, MS
Principal Investigator
Harvard School of Dental Medicine, Boston, USA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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