Bone Graft; Complications, Infection or Inflammation, Dental Implant, Ridge Deficency
Conditions
Keywords
Keratinized Tissue, Keratinized mucosa, attached mucosa, dental implants, ridge augmentation, guided bone regeneration, connective tissue graft, acellular demral matrix
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: 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
Interventions
PROCEDUREConnective 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
PROCEDUREAcellular 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
PROCEDURENo 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) | From baseline to 6 months | The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe. |
| Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm) | From baseline to 6 months | The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan. |
| Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin | 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. |
| Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin | From baseline to 6 months | The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan. |
Countries
United States
Participant flow
Recruitment details
Patients in the School of Dentistry Periodontology Clinic in need of grafting treatment will be told about the study and if interested in participation will be scheduled for a screening visit for study entry by periodontal residents and faculty members. Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12.
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 8 |
| 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
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 | 8 |
| No Soft Tissue Graft (Control) 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.
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. | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Connective Tissue Graft | Acellular Dermal Matrix | No Soft Tissue Graft (Control) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 3 Participants | 4 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 6 Participants | 7 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 8 Participants | 22 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)
The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.
Time frame: From baseline to 6 months
Population: Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Connective Tissue Graft | Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) | 1.96 mm | Standard Deviation 1.05 |
| Acellular Dermal Matrix | Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) | 1.59 mm | Standard Deviation 1.06 |
| No Soft Tissue Graft (Control) | Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) | 0.33 mm | Standard Deviation 1 |
Primary
Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin
The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe.
Time frame: From baseline to 6 months
Population: Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Connective Tissue Graft | Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin | 2.38 mm | Standard Deviation 1.32 |
| Acellular Dermal Matrix | Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin | 1.37 mm | Standard Deviation 1.2 |
| No Soft Tissue Graft (Control) | Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin | 0.15 mm | Standard Deviation 1.65 |
Primary
Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Time frame: From baseline to 6 months
Population: Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Connective Tissue Graft | Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm) | 1.65 mm | Standard Deviation 0.95 |
| Acellular Dermal Matrix | Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm) | 0.74 mm | Standard Deviation 0.93 |
| No Soft Tissue Graft (Control) | Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm) | -0.09 mm | Standard Deviation 0.61 |
Primary
Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Time frame: From baseline to 6 months
Population: Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Connective Tissue Graft | Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin | 1.75 mm | Standard Deviation 0.87 |
| Acellular Dermal Matrix | Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin | 1.23 mm | Standard Deviation 0.7 |
| No Soft Tissue Graft (Control) | Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin | 0.71 mm | Standard Deviation 0.57 |