Trial Outcomes & Findings for Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material (NCT NCT02698163)
NCT ID: NCT02698163
Last Updated: 2022-01-21
Results Overview
A radiograph of the treated tooth is made after 6 months post treatment, which will be compared with the radiograph of the treated tooth taken immediately after the RCT procedure. Clinical examination is performed at 6 months after the operation. The greatest diameters (mm) of the radio-lucency were recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
6 months
Results posted on
2022-01-21
Participant Flow
Participant milestones
| Measure |
Gutta Percha
For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth. One tooth per participant was treated.
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Nanodiamond Reinforced Gutta Percha
For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls). One tooth per participant was treated.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Gutta Percha
For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth. One tooth per participant was treated.
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Nanodiamond Reinforced Gutta Percha
For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls). One tooth per participant was treated.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gutta Percha
n=1 Participants
For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Nanodiamond Reinforced Gutta Percha
n=3 Participants
For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 0 • n=1 Participants
|
67 years
STANDARD_DEVIATION 21.66 • n=3 Participants
|
68.25 years
STANDARD_DEVIATION 17.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
3 participants
n=3 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.
A radiograph of the treated tooth is made after 6 months post treatment, which will be compared with the radiograph of the treated tooth taken immediately after the RCT procedure. Clinical examination is performed at 6 months after the operation. The greatest diameters (mm) of the radio-lucency were recorded.
Outcome measures
| Measure |
Gutta Percha
n=1 Participants
For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Nanodiamond Reinforced Gutta Percha
n=2 Participants
For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
|---|---|---|
|
Percent Reduction in Apical Radio-lucency
|
17.4 % Change in Diameter (mm)
Standard Deviation 0
|
27.1 % Change in Diameter (mm)
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: 1 yearPopulation: One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.
Apical periodontitis resulting in pain and apical lucency is measured. A radiograph of the treated tooth is made after 1 year post treatment, which will be compared with the radiographs of the treated tooth taken immediately after the RCT procedure and 6 months post treatment. Clinical examination is performed at 1 year after the operation.
Outcome measures
| Measure |
Gutta Percha
n=1 Participants
For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Nanodiamond Reinforced Gutta Percha
n=2 Participants
For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
|---|---|---|
|
Number of Participants With Absence of Apical Periodontitis
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.
Clinical examination is performed at 6 month after the operation to determine post-operative pain. Pain was assessed via a postoperative survey and a clinical examination (comparative pain scale 0 - 10; 0 is no pain and 10 is spontaneous pain).
Outcome measures
| Measure |
Gutta Percha
n=1 Participants
For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Nanodiamond Reinforced Gutta Percha
n=2 Participants
For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
|---|---|---|
|
Number of Participants With Post-Operative Pain
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.
A radiograph of the treated tooth is made after 6 months post treatment, which will be compared with the radiograph of the treated tooth taken immediately after the RCT procedure. Clinical examination is performed at 6 months after the operation.
Outcome measures
| Measure |
Gutta Percha
n=1 Participants
For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Nanodiamond Reinforced Gutta Percha
n=2 Participants
For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
|---|---|---|
|
Number of Participants With Tooth Survival (6 Month)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.
A radiograph of the treated tooth is made after 1 year post treatment, which will be compared with the radiographs of the treated tooth taken immediately after the RCT procedure and 6 months post treatment. Clinical examination is performed at 1 year after the operation.
Outcome measures
| Measure |
Gutta Percha
n=1 Participants
For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
Nanodiamond Reinforced Gutta Percha
n=2 Participants
For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.
Nanodiamond reinforced Gutta Percha: Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Gutta Percha: Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
|
|---|---|---|
|
Number of Participants With Tooth Survival (1 Year)
|
1 Participants
|
2 Participants
|
Adverse Events
Gutta Percha
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nanodiamond Reinforced Gutta Percha
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