Comparison of Two Different Surgical Approaches To Increase Peri-Implant

Status Completed

Clinical Trial Summary

The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults.

AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of the American Association of Tissue Banks (AATB).

Twenty adult subjects will be recruited who are in need of dental implant placement with simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the subjects will be randomized to the ADM group and half will be randomized to the sCTG group. The surgical intervention will be performed according to the protocol and subjects will return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of healing, gum thickness, subject perception of pain, and esthetic photographs.

Clinical Trial Description

Although little is known about the influence of peri-implant mucosa thickness (PMT) on long-term biologic outcomes, soft tissue thickness is a critical component to esthetic dental implant restorations. While the subepithelial connective tissue graft (sCTG) has been recognized as the gold standard for gingival augmentation, several studies have reported acellular dermal matrix (ADM) may produce similar outcomes. Healthy patients with a thin biotype were selected on the basis of an eligibility criteria and randomized to the control (sCTG) or test (ADM) group. Measurements were completed by a masked examiner at baseline and at implant uncovering. Patient reported outcomes were recorded, as well. A power analysis suggested 20 subjects be recruited. The gain in PMT at 1mm, 3mm and 5mm from the expected CEJ and recipient site wound dehiscence were measured and recorded in both groups at different time points by a calibrated, masked examiner. Patient-related outcome measures (PROMs), such as pain and level of satisfaction with final outcome, were also recorded for all study participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02450383
Study type	Interventional
Source	University of Iowa
Contact
Status	Completed
Phase	Phase 4
Start date	January 2015
Completion date	September 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05498662` - An Observational Study of the T3 Pro Dental Implant System
Active, not recruiting	`NCT05311657` - Oral Health and Severe COPD
Completed	`NCT01237184` - Initial Stability of Posterior Maxillary Implants With Bicortical Fixation
Not yet recruiting	`NCT03521024` - Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics	N/A
Recruiting	`NCT04856319` - The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success	N/A
Active, not recruiting	`NCT05079542` - RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases.	N/A
Recruiting	`NCT03003819` - A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management	N/A
Completed	`NCT02163395` - Performance Evaluation of FullCeram Implants in Single Tooth Gaps	N/A
Completed	`NCT02996370` - Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial	N/A
Completed	`NCT02842385` - Soft Tissue Thickness on Submerged and Non Submerged Implants	N/A
Withdrawn	`NCT00798031` - Case Series Evaluation of a Short Dental Implant	N/A
Completed	`NCT04559802` - Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation	N/A
Completed	`NCT00018512` - Biological Specifications for Denture Designs	Phase 2
Enrolling by invitation	`NCT05157009` - Immediate Implant Outcomes With and Without Bone Augmentation	N/A
Active, not recruiting	`NCT04550689` - Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft	N/A
Terminated	`NCT03580798` - Ridge Preservation Comparing Simultaneous vs. Delayed Grafting	N/A
Completed	`NCT05016401` - Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant
Not yet recruiting	`NCT05096897` - Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)
Recruiting	`NCT04605445` - One vs Two Visits Root Canal Treatments in Infected Teeth	N/A
Enrolling by invitation	`NCT04938089` - Effect of Periodontal Maintenance Therapy on Tooth Loss in Regular and Irregular Compliant Smokers and Non-Smokers: A Cohort Retrospective Analysis With a Follow-up Up to 40 Years

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms