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

Primary Purpose

Bone Graft; Complications, Infection or Inflammation, Ridge Deficency, Dental Implant

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connective tissue graft at time of bone graft
Acellular Demal Matrix at time of bone graft
No soft tissue grafting at time of bone graft
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Graft; Complications, Infection or Inflammation focused on measuring Keratinized Tissue, Keratinized mucosa, attached mucosa, dental implants, ridge augmentation, guided bone regeneration, connective tissue graft, acellular demral matrix

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Be a registered University of Alabama at Birmingham (UAB) dental school patient
  2. English Speaking
  3. Healthy enough to undergo the proposed therapy
  4. Demonstrated willingness to comply with study directions and time-line
  5. 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.
  6. Able to read and understand the informed consent form
  7. Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.

Exclusion Criteria:

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

Sites / Locations

  • Unversity of Alabama at Birmingham, School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

connective tissue graft

Acellular Dermal Matrix

No soft tissue graft

Arm Description

Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.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 Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.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

Control group where no soft tissue graft is added to the lateral ridge augmentation.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.

Outcomes

Primary Outcome Measures

quality of soft tissue regenerated
Compare the increase in soft tissue quality (attached or keratinized ) between two commonly used soft tissue grafts
Any influence on the soft tissue outcomes
Compare the amount of bone graft gained when either soft tissue grafts added
Measure changes in tissue thickness (in mm) between ADM and CTG
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between CTG and ADM following soft tissue grafting.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2018
Last Updated
December 7, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03774888
Brief Title
To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.
Official Title
A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Graft; Complications, Infection or Inflammation, Ridge Deficency, Dental Implant
Keywords
Keratinized Tissue, Keratinized mucosa, attached mucosa, dental implants, ridge augmentation, guided bone regeneration, connective tissue graft, acellular demral matrix

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
connective tissue graft
Arm Type
Experimental
Arm Description
Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.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
Arm Title
Acellular Dermal Matrix
Arm Type
Experimental
Arm Description
Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.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
Arm Title
No soft tissue graft
Arm Type
Active Comparator
Arm Description
Control group where no soft tissue graft is added to the lateral ridge augmentation.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.
Intervention Type
Procedure
Intervention Name(s)
Connective tissue graft at time of bone graft
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Acellular Demal Matrix at time of bone graft
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
No soft tissue grafting at time of bone graft
Intervention Description
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 Outcome Measure Information:
Title
quality of soft tissue regenerated
Description
Compare the increase in soft tissue quality (attached or keratinized ) between two commonly used soft tissue grafts
Time Frame
From baseline to 6 months
Title
Any influence on the soft tissue outcomes
Description
Compare the amount of bone graft gained when either soft tissue grafts added
Time Frame
From baseline to 6 months
Title
Measure changes in tissue thickness (in mm) between ADM and CTG
Description
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between CTG and ADM following soft tissue grafting.
Time Frame
: From baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hussein Basma, DDS, MS
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Alabama at Birmingham, School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States

12. IPD Sharing Statement

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

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