Trial Outcomes & Findings for The Use of Platelet Rich Fibrin in Pulpal and Periodontal Regeneration in Mature Teeth (NCT NCT02477358)
NCT ID: NCT02477358
Last Updated: 2023-10-04
Results Overview
Teeth (units) measuring vital via the following tests: thermal, percussion. Thermal was utilized with endo cold spray and percussion from tapping on teeth with mouth mirror.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
3-11 months. Each participant was measured for as long as it took to complete their prosthesis. The minimum study duration was 3 months and the maximum duration was 11 months in one subject.
Results posted on
2023-10-04
Participant Flow
Patient's were recruited from the UNMC Dental School
No pre-assignment details were completed prior to assignment to an arm/group
Unit of analysis: Teeth
Participant milestones
| Measure |
PRF Treatment
All study participants are scheduled for teeth extraction. Subjects will be randomized to either receive either left tooth PRF; right tooth reimplantation, OR right tooth PRF; left tooth reimplantation. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects teeth will have PRF endodontic revascularization therapy and the other teeth will be reimplanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
|
No Treatment
All study participants are scheduled for teeth extraction. Subjects will be randomized to either receive either left tooth PRF; right tooth reimplantation, OR right tooth PRF; left tooth reimplantation. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects teeth will have PRF endodontic revascularization therapy and the other teeth will be reimplanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
|
|---|---|---|
|
Overall Study
STARTED
|
18 36
|
18 36
|
|
Overall Study
COMPLETED
|
18 35
|
18 35
|
|
Overall Study
NOT COMPLETED
|
0 1
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Units were not evenly split between male/female gender. A larger proportion of total units were measured in male participants.
Baseline characteristics by cohort
| Measure |
PRF Treatment
n=35 Teeth
All study participants are scheduled for teeth extraction (between 2 to 6 teeth per participant). Subjects will be randomized to either receive either left tooth PRF; right tooth re-implantation, OR right tooth PRF; left tooth re implantation. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for at least 3 months (up to 11 months) and then tested for vitality before extracting and examining histologically.
All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects teeth will have PRF endodontic revascularization therapy. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
|
No Treatment
n=35 Teeth
All study participants are scheduled for teeth extraction (between 2 to 6 teeth per participant). Subjects will be randomized to either receive either left tooth PRF; right tooth re-implantation, OR right tooth PRF; left tooth re-implantation. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months (up to 11 months) and then tested for vitality before extracting and examining histologically.
All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects teeth will be re implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
|
Total
n=70 Teeth
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=176 Teeth
|
58.5 years
n=13 Teeth
|
58.5 years
n=13 Teeth
|
|
Sex: Female, Male
Female
|
17 Teeth
n=176 Teeth • Units were not evenly split between male/female gender. A larger proportion of total units were measured in male participants.
|
17 Teeth
n=13 Teeth • Units were not evenly split between male/female gender. A larger proportion of total units were measured in male participants.
|
34 Teeth
n=13 Teeth • Units were not evenly split between male/female gender. A larger proportion of total units were measured in male participants.
|
|
Sex: Female, Male
Male
|
18 Teeth
n=176 Teeth • Units were not evenly split between male/female gender. A larger proportion of total units were measured in male participants.
|
18 Teeth
n=13 Teeth • Units were not evenly split between male/female gender. A larger proportion of total units were measured in male participants.
|
36 Teeth
n=13 Teeth • Units were not evenly split between male/female gender. A larger proportion of total units were measured in male participants.
|
|
Pre-treatment Tooth Vitality to Thermal and Percussion Sensitivity
Pre Thermal
|
.852 Teeth
STANDARD_DEVIATION .089 • n=176 Teeth
|
.939 Teeth
STANDARD_DEVIATION .048 • n=13 Teeth
|
.8955 Teeth
STANDARD_DEVIATION .0685 • n=13 Teeth
|
|
Pre-treatment Tooth Vitality to Thermal and Percussion Sensitivity
Pre Percussion
|
.121 Teeth
STANDARD_DEVIATION .066 • n=176 Teeth
|
.092 Teeth
STANDARD_DEVIATION .056 • n=13 Teeth
|
.1065 Teeth
STANDARD_DEVIATION .061 • n=13 Teeth
|
|
Pre-treatment Tooth Vitality to Electric Pulp Test (EPT)
|
34.0 EPT Units (0-80)
STANDARD_DEVIATION 3.0 • n=176 Teeth
|
33.1 EPT Units (0-80)
STANDARD_DEVIATION 3.0 • n=13 Teeth
|
33.5 EPT Units (0-80)
STANDARD_DEVIATION 3.0 • n=13 Teeth
|
PRIMARY outcome
Timeframe: 3-11 months. Each participant was measured for as long as it took to complete their prosthesis. The minimum study duration was 3 months and the maximum duration was 11 months in one subject.Population: Half of the subjects teeth will have PRF endodontic revascularization therapy and the other teeth will be reimplanted only without PRF endodontic reveascularization therapy.
Teeth (units) measuring vital via the following tests: thermal, percussion. Thermal was utilized with endo cold spray and percussion from tapping on teeth with mouth mirror.
Outcome measures
| Measure |
Experimental: PRF Treated
n=35 Teeth
Teeth Extracted and reimplanted after PRF endodontic revascularization therapy. Splinted to adjacent teeth. Monitored for 3 months then tested for vitality (EPT, Thermal, Percussion), extracted, histologically examined.
|
No Intervention: Control
n=35 Teeth
Teeth Extracted and reimplanted. Splinted to adjacent teeth. Monitored for 3 months then tested for vitality (EPT, Thermal, Percussion), extracted, histologically examined.
|
|---|---|---|
|
Vitality of Teeth (Units) Using Thermal and Percussion Sensitivity Trend Observed During Study Duration (3-11 Months)
Teeth with Thermal Sensitivity Results
|
.559 Teeth
Standard Deviation .120
|
.592 Teeth
Standard Deviation .118
|
|
Vitality of Teeth (Units) Using Thermal and Percussion Sensitivity Trend Observed During Study Duration (3-11 Months)
Teeth with Percussion Sensitivity Results
|
.065 Teeth
Standard Deviation .046
|
.040 Teeth
Standard Deviation .034
|
PRIMARY outcome
Timeframe: 3-11 months. Each participant was measured for as long as it took to complete their prosthesis. The minimum study duration was 3 months and the maximum duration was 11 months in one subject.Population: Half of the subjects teeth will have PRF endodontic revascularization therapy and the other teeth will be reimplanted only without PRF endodontic reveascularization therapy.
Teeth (units) measuring vital via the following tests: EPT utilizing EPT units (0-80). There is no specific number that suggests vital vs un-vital but rather it is a trend towards un-vital which is determined as 80.
Outcome measures
| Measure |
Experimental: PRF Treated
n=35 Teeth
Teeth Extracted and reimplanted after PRF endodontic revascularization therapy. Splinted to adjacent teeth. Monitored for 3 months then tested for vitality (EPT, Thermal, Percussion), extracted, histologically examined.
|
No Intervention: Control
n=35 Teeth
Teeth Extracted and reimplanted. Splinted to adjacent teeth. Monitored for 3 months then tested for vitality (EPT, Thermal, Percussion), extracted, histologically examined.
|
|---|---|---|
|
Vitality of Teeth Using Electronic Pulp Test (EPT Units) Trend Observed During Study Duration (3-11 Months)
|
57 EPT Units (0-80)
Standard Deviation 3.79
|
55.45 EPT Units (0-80)
Standard Deviation 3.81
|
Adverse Events
Experimental: PRF Treated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention: 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place