Trial Outcomes & Findings for Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration. (NCT NCT03102879)

Last Updated: 2020-01-21

Results Overview

Efficacy (functionality) was defined when one year after the intervention, the treated tooth remains in the mouth, without pain to percussion test and with apical bone lesion of equal size in the three senses of space or a decrease in some of them or no more than 0.1 mm increase of one of them.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

12 months

Results posted on

2020-01-21

Participant Flow

Recruitment between September 2016 and September 2017, from patients referred for endodontic treatment to the Universidad de los Andes Health Center, located in San Bernardo city, Santiago, Chile.

Participant milestones

Participant milestones
Measure	Regenerative Procedure Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.	Endodontic Treatment Conventional root canal treatment treatment with inert product gutapercha.
Overall Study STARTED	18	18
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regenerative Procedure n=18 Participants Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.	Endodontic Treatment n=18 Participants Conventional root canal treatment treatment with inert product gutapercha.	Total n=36 Participants Total of all reporting groups
Age, Continuous	27 years n=18 Participants	28 years n=18 Participants	27 years n=36 Participants
Sex: Female, Male Female	12 Participants n=18 Participants	13 Participants n=18 Participants	25 Participants n=36 Participants
Sex: Female, Male Male	6 Participants n=18 Participants	5 Participants n=18 Participants	11 Participants n=36 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Regenerative Procedure n=18 Participants Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.	Endodontic Treatment n=18 Participants Conventional root canal treatment treatment with inert product gutapercha.
Number of Participats Showing Efficacy (Functionality)	18 Participants	18 Participants

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Change in pulpal response (period 1 year) will be assessed through response to sensitivity tests (cold, hot and electrical test) in teeth treated with regenerative procedure and conventional endodontic treatment during time.

Outcome measures

Outcome measures
Measure	Regenerative Procedure n=18 Participants Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.	Endodontic Treatment n=18 Participants Conventional root canal treatment treatment with inert product gutapercha.
Change in Pulpal Response Basal Cold Test · Response	1 Participants	1 Participants
Change in Pulpal Response Basal Cold Test · No Response	17 Participants	17 Participants
Change in Pulpal Response Basal Hot Test · Response	0 Participants	1 Participants
Change in Pulpal Response Basal Electrical Test · Response	3 Participants	1 Participants
Change in Pulpal Response Basal Electrical Test · No Response	15 Participants	17 Participants
Change in Pulpal Response 6 months Cold Test · Response	14 Participants	2 Participants
Change in Pulpal Response 6 months Cold Test · No Response	4 Participants	16 Participants
Change in Pulpal Response 6 months Hot Test · Response	2 Participants	0 Participants
Change in Pulpal Response 6 months Hot Test · No Response	16 Participants	18 Participants
Change in Pulpal Response 6 months Electrical Test · Response	4 Participants	4 Participants
Change in Pulpal Response 6 months Electrical Test · No Response	14 Participants	14 Participants
Change in Pulpal Response 12 months Cold Test · Response	10 Participants	1 Participants
Change in Pulpal Response 12 months Cold Test · No Response	8 Participants	17 Participants
Change in Pulpal Response 12 months Hot Test · Response	5 Participants	0 Participants
Change in Pulpal Response 12 months Hot Test · No Response	13 Participants	18 Participants
Change in Pulpal Response 12 months Electrical Test · Response	9 Participants	3 Participants
Change in Pulpal Response 12 months Electrical Test · No Response	9 Participants	15 Participants
Change in Pulpal Response Basal Hot Test · No Response	18 Participants	17 Participants

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Change in apical lesion size will be evaluated by cone beam tomography 6 and 12 months after intervention is completed.

Outcome measures

Outcome measures
Measure	Regenerative Procedure n=18 Participants Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.	Endodontic Treatment n=18 Participants Conventional root canal treatment treatment with inert product gutapercha.
Change in Apical Lesion Size Basal Mesio-Distal	5 milimeters Interval 4.2 to 7.7	5.5 milimeters Interval 3.3 to 6.7
Change in Apical Lesion Size Basal Height	5.5 milimeters Interval 4.7 to 8.9	7.1 milimeters Interval 2.9 to 10.1
Change in Apical Lesion Size Basal Antero-Posterior	5 milimeters Interval 4.6 to 6.0	5.1 milimeters Interval 3.3 to 6.2
Change in Apical Lesion Size 6 months Mesio-Distal	2.7 milimeters Interval 2.0 to 5.1	2.4 milimeters Interval 0.9 to 5.9
Change in Apical Lesion Size 6 months Height	2.6 milimeters Interval 2.4 to 4.6	2.5 milimeters Interval 1.4 to 4.3
Change in Apical Lesion Size 6 months Antero-Posterior	2.4 milimeters Interval 2.2 to 4.4	3 milimeters Interval 1.7 to 4.0
Change in Apical Lesion Size 12 months Mesio-Distal	2 milimeters Interval 1.4 to 3.4	1.7 milimeters Interval 0.9 to 3.4
Change in Apical Lesion Size 12 months Height	1.8 milimeters Interval 0.8 to 4.1	1.5 milimeters Interval 0.4 to 4.4
Change in Apical Lesion Size 12 months Anterio-Posterior	2.1 milimeters Interval 1.1 to 4.1	1.7 milimeters Interval 0.6 to 3.3

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

To compare pain to percussion in a period of 1 year in permanent teeth with mature apex and apical lesion, treated with a regenerative endodontic procedure and conventional endodontic therapy. This will be monitored 6 and 12 months after the procedure is completed. Pain to percussion positive: The tooth is tenderness when is softly tapped with handle end of a dental mirror at examination time. Pain to percussion negative: The tooth is not tenderness when is softly tapped with handle end of a dental mirror at examination time.

Outcome measures

Outcome measures
Measure	Regenerative Procedure n=18 Participants Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.	Endodontic Treatment n=18 Participants Conventional root canal treatment treatment with inert product gutapercha.
Pain to Percussion Baseline Pain to Percussion · Positive	11 Participants	5 Participants
Pain to Percussion Baseline Pain to Percussion · Negative	7 Participants	13 Participants
Pain to Percussion 6 months Pain to Percussion · Positive	1 Participants	0 Participants
Pain to Percussion 6 months Pain to Percussion · Negative	17 Participants	18 Participants
Pain to Percussion 12 months Pain to Percussion · Positive	0 Participants	0 Participants
Pain to Percussion 12 months Pain to Percussion · Negative	18 Participants	18 Participants

SECONDARY outcome

Timeframe: 6 months, 12 months

To describe adverse events in a period of 1 year in permanent teeth with mature apex and apical lesion, operated with a regenerative endodontic procedure and conventional endodontic therapy.

Outcome measures

Outcome measures
Measure	Regenerative Procedure n=18 Participants Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.	Endodontic Treatment n=18 Participants Conventional root canal treatment treatment with inert product gutapercha.
Numbers of Participants With Adverse Event 6 months	0 Participants	0 Participants
Numbers of Participants With Adverse Event 12 months	0 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: This outcome was not measured in conventional treatment group due to the nature of the filling material, which does not promote revitalization of the pulp.

To describe the pulp regeneration by means of vitality test using Doppler laser flowmetry (LDF) in a period of 1 year in permanent teeth with mature apex and apical lesion treated with a regenerative endodontic procedure. The vitality of the teeth was measured by LDF and the perfusion units (PU) percentage of the tooth under study was determined with respect to a healthy control tooth with similar anatomical characteristics from the same patient.

Outcome measures

Outcome measures
Measure	Regenerative Procedure n=18 Participants Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.	Endodontic Treatment Conventional root canal treatment treatment with inert product gutapercha.
Pulp Regeneration Basal	60.6 % PU in time in relation to controltooth Interval 53.5 to 75.0	—
Pulp Regeneration 6 months	74.4 % PU in time in relation to controltooth Interval 49.2 to 102.2	—
Pulp Regeneration 12 months	78.1 % PU in time in relation to controltooth Interval 54.7 to 99.3	—

Adverse Events

Regenerative Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Treatment

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

Claudia Brizuela

Universidad de los Andes

Phone: 56 2 26181166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place