RECRUITING

Vertical Soft Tissue Augmentation With CTG vs ADM

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Conditions

Implant Complication

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative

Official Title

Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial

Quick Facts

Study Start:2023-05-26
Study Completion:2026-11-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05729607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Periodontally and systemically healthy
  3. * Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
  4. * Presence of single functional dental implant in the anterior with a PSTD
  5. * Implants diagnosed as healthy (Berglundh et al., 2018)
  6. * Contraindications for surgery
  7. * Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing
  8. * Patients pregnant or attempting to get pregnant (self-reported)
  9. * Untreated periodontitis
  10. * Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018)
  11. * Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded
  12. * History of soft tissue grafting at the implant site within the last 6 months
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lorenzo Tavelli, DDS, MS
CONTACT
734-604-4364
lorenzo_tavelli@hsdm.harvard.edu

Principal Investigator

Lorenzo Tavelli, DDS, MS
PRINCIPAL_INVESTIGATOR
Harvard School of Dental Medicine, Boston, USA

Study Locations (Sites)

Harvard School of Dental Medicine
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Harvard Medical School (HMS and HSDM)

  • Lorenzo Tavelli, DDS, MS, PRINCIPAL_INVESTIGATOR, Harvard School of Dental Medicine, Boston, USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-26
Study Completion Date2026-11-27

Study Record Updates

Study Start Date2023-05-26
Study Completion Date2026-11-27

Terms related to this study

Additional Relevant MeSH Terms

  • Implant Complication