Trial Outcomes & Findings for To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure. (NCT NCT03774888)
NCT ID: NCT03774888
Last Updated: 2024-05-09
Results Overview
The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
From baseline to 6 months
Results posted on
2024-05-09
Participant Flow
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.
Unit of analysis: dental implant site
Participant milestones
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8 13
|
8 16
|
8 12
|
|
Overall Study
COMPLETED
|
8 13
|
8 16
|
8 12
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.
Baseline characteristics by cohort
| Measure |
Connective Tissue Graft
n=8 Participants
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
|
Acellular Dermal Matrix
n=8 Participants
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
|
No Soft Tissue Graft (Control)
n=8 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From baseline to 6 monthsPopulation: 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.
The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.
Outcome measures
| Measure |
Connective Tissue Graft
n=13 dental implant site
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
|
Acellular Dermal Matrix
n=16 dental implant site
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
|
No Soft Tissue Graft (Control)
n=12 dental implant site
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.
|
|---|---|---|---|
|
Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)
|
1.96 mm
Standard Deviation 1.05
|
1.59 mm
Standard Deviation 1.06
|
0.33 mm
Standard Deviation 1
|
PRIMARY outcome
Timeframe: From baseline to 6 monthsPopulation: 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.
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Outcome measures
| Measure |
Connective Tissue Graft
n=13 dental implant site
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
|
Acellular Dermal Matrix
n=16 dental implant site
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
|
No Soft Tissue Graft (Control)
n=12 dental implant site
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.
|
|---|---|---|---|
|
Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)
|
1.65 mm
Standard Deviation 0.95
|
0.74 mm
Standard Deviation 0.93
|
-0.09 mm
Standard Deviation 0.61
|
PRIMARY outcome
Timeframe: From baseline to 6 monthsPopulation: 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.
The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe.
Outcome measures
| Measure |
Connective Tissue Graft
n=13 dental implant site
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
|
Acellular Dermal Matrix
n=16 dental implant site
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
|
No Soft Tissue Graft (Control)
n=12 dental implant site
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.
|
|---|---|---|---|
|
Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin
|
2.38 mm
Standard Deviation 1.32
|
1.37 mm
Standard Deviation 1.2
|
0.15 mm
Standard Deviation 1.65
|
PRIMARY outcome
Timeframe: From baseline to 6 monthsPopulation: 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.
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Outcome measures
| Measure |
Connective Tissue Graft
n=13 dental implant site
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
|
Acellular Dermal Matrix
n=16 dental implant site
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
|
No Soft Tissue Graft (Control)
n=12 dental implant site
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.
|
|---|---|---|---|
|
Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin
|
1.75 mm
Standard Deviation 0.87
|
1.23 mm
Standard Deviation 0.7
|
0.71 mm
Standard Deviation 0.57
|
Adverse Events
Connective Tissue Graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acellular Dermal Matrix
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Soft Tissue Graft (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hussein Basma, DDS, MS
University of Alabama at Birmingham
Phone: 2059344506
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place