Clinical trial NCT02450383: Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness
Official title: Comparison of Two Different Surgical Approaches to Increase Peri-Implant Mucosa Thickness: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Loss
Peri-implant Mucosa Defect
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2015-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion criteria:

* Age: 18 to 80 years.
* Subjects must be able and willing to follow instructions related to the study procedures.
* Subjects must have read, understood and signed an informed consent form.
* At least one single-tooth edentulous site, with adjacent natural teeth, planned for tooth replacement therapy with an implant-supported restoration.

Exclusion criteria:

* Reported allergy or hypersensitivity to any of the products to be used in the study.
* Severe hematologic disorders, such as hemophilia or leukemia.
* Active severe infectious diseases that may compromise normal healing.
* Liver or kidney dysfunction/failure.
* Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
* Subjects with uncontrolled diabetes, defined as Hba1c \> 6.5% (According to the American Diabetes Association 2014 Guidelines)
* Pregnant women or nursing mothers.
* Smokers: Subjects who have smoked within 6 months of study onset.
* Concomitant medications for systemic conditions that may affect the outcomes of the study.
* Any other non-specified reason that from the point of view of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).

Primary outcomes:
measure: Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery
timeFrame: Baseline and 16 weeks after baseline
Secondary outcomes:
measure: Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery
timeFrame: Baseline to 16 weeks after baseline
measure: Patient-perceived Discomfort, Measured by VAS
timeFrame: 2 weeks
measure: Wound Healing, Measured Using a Standardized Visual Wound Healing Index
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa College of Dentistry - Craniofacial Clinical Research Center and Department of Periodontics
state: Iowa
Study officials:
affiliation: University of Iowa College of Dentistry
name: Gustavo Avila-Ortiz, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hutton CG, Johnson GK, Barwacz CA, Allareddy V, Avila-Ortiz G. Comparison of two different surgical approaches to increase peri-implant mucosal thickness: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):807-814. doi: 10.1002/JPER.17-0597. Epub 2018 Jul 20.