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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Active, not recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.