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

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ClinicalTrials.gov Identifier: NCT03774888
Recruitment Status : Not yet recruiting
First Posted : December 13, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hussein Basma, University of Alabama at Birmingham

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.


Condition or disease Intervention/treatment Phase
Bone Graft; Complications, Infection or Inflammation Ridge Deficency Dental Implant Procedure: Connective tissue graft at time of bone graft Procedure: Acellular Demal Matrix at time of bone graft Procedure: No soft tissue grafting at time of bone graft Not Applicable

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:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: connective tissue graft
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
Procedure: Connective tissue graft at time of bone graft
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

Experimental: Acellular Dermal Matrix
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
Procedure: Acellular Demal Matrix at time of bone graft
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

Active Comparator: No 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.
Procedure: No soft tissue grafting at time of bone graft
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 Measures :
  1. quality of soft tissue regenerated [ Time Frame: From baseline to 6 months ]
    Compare the increase in soft tissue quality (attached or keratinized ) between two commonly used soft tissue grafts

  2. Any influence on the soft tissue outcomes [ Time Frame: From baseline to 6 months ]
    Compare the amount of bone graft gained when either soft tissue grafts added

  3. Measure changes in tissue thickness (in mm) between ADM and CTG [ Time Frame: : From baseline to 6 months ]
    Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between CTG and ADM following soft tissue grafting.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774888


Contacts
Contact: Hussein Basma, DDS, MS 934-7513 basma86@uab.edu
Contact: Sarah Startley, DMD 975-8711 ss1971@uab.edu

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Hussein Basma, DDS, MS University of Alabama at Birmingham

Responsible Party: Hussein Basma, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03774888     History of Changes
Other Study ID Numbers: HSB-1
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hussein Basma, University of Alabama at Birmingham:
Keratinized Tissue
Keratinized mucosa
attached mucosa
dental implants
ridge augmentation
guided bone regeneration
connective tissue graft
acellular demral matrix

Additional relevant MeSH terms:
Inflammation
Pathologic Processes