A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants

N/ACompletedNCT01934530

University of Michigan13 enrolled

Overview

This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).

Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Implant Soft Tissue Defects in the Anterior Maxilla

Interventions

Soft Tissue GraftingPROCEDURE

All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared. Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults of at least 18 years of age * Maxillary non-molar implant with failing pink esthetic profile * Implants with adjacent landmarks (only one can be an implant) * Healthy implants measured by the lack of peri-implantitis and mucositis * Good oral hygiene. Exclusion Criteria: * Unstable systemic diseases, compromised immune system, or unstable bleeding disorders * History of radiation or cancer in the oral cavity * Use of IV bisphosphonate or steroid medication * Use of tobacco products (\>1/2 pack per day) * Pregnancy * Mucogingival surgery or implant placement within the past six months

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Recession Correction

Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.

Time frame: 6 Months

Secondary Outcomes

Concavity Correction

At baseline, 6 weeks, 3 months, and 6 months after grafting, buccal concavities were measured.

Time frame: 6 Months

Data from ClinicalTrials.gov

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