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OpenTrials
Completed

NCT Number: NCT03774888

To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.

This study will compare two commonly used soft tissue grafting techniques (connective tissue graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral ridge augmentation procedure.

Following ridge augmentation procedure, most of the times there is a need for soft tissue augmentation to change the quality of the tissue around future implant's site. To our knowledge, the influence of soft tissue augmentation at the time of ridge augmentation procedure has not been tested defects.

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Key information

Conditions

Bone Graft; Complications, Infection or Inflammation Dental Implant Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Ridge Deficency

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

About this study

Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Ridge augmentation procedure can alter the quality of tissue in the sites where it will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation procedure.

Specific aims for this project include the evaluation of:

  • To evaluate the quality of soft tissue regenerated with the use of the two available soft tissue grafts via histological analysis.
  • To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR) procedures.
  • To quantify the soft tissue augmentation achieved by the two available soft tissue grafts by direct clinical measurements after the healing

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be a registered University of Alabama at Birmingham (UAB) dental school patient
  • English Speaking
  • Healthy enough to undergo the proposed therapy
  • Demonstrated willingness to comply with study directions and time-line
  • Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.
  • Able to read and understand the informed consent form
  • Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.

Exclusion criteria

  • No English Speaking
  • Smokers/ tobacco users (>10 cigarettes a day)
  • Less than 18 years old
  • Know hypersensitivity to titanium
  • Patients with significant medical conditions or habbits expected to interfere with bony healing.
  • Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
  • Bone dehiscence of >4mm following tooth extraction or Vertical loss of bone at edentulous ridge

Treatment and study plan

Connective tissue graft at time of bone graft

Procedure

following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft

Acellular Demal Matrix at time of bone graft

Procedure

following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft

No soft tissue grafting at time of bone graft

Procedure

Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.

Primary outcomes

  1. Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)

    Time frame: From baseline to 6 months

    The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.

  2. Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)

    Time frame: From baseline to 6 months

    The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.

  3. Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin

    Time frame: From baseline to 6 months

    The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe.

  4. Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin

    Time frame: From baseline to 6 months

    The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Dec 13, 2018
Registry last updated
May 9, 2024

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.

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