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Completed

NCT Number: NCT01934530

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

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).

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Key information

Conditions

Dental Implant Soft Tissue Defects in the Anterior Maxilla

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soft Tissue Grafting

Procedure

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.

Primary outcomes

  1. Recession Correction

    Time frame: 6 Months

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

Secondary outcomes

  1. Concavity Correction

    Time frame: 6 Months

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

Other outcomes

  1. Tissue Thickness

    Time frame: 6 Months

    Tissue thickness was measured with a 25 endodontic file with rubber stopper at baseline, 6 weeks, 3 months and 6 months after grafting.

  2. Implant Esthetics

    Time frame: 6 Months

    Implant esthetics were rated with written survey by both the subject and clinician.

  3. Psychosocial Data

    Time frame: 6 months

    Subjects completed questionnaires regarding their quality of life during the study by written survey.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • BioHorizons, Inc.

Registry information

Official study title

Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 4, 2013
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.