Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth
Primary Purpose
Pulp Necrosis, Periapical Lesion, Anterior Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single visit pulp regeneration
Two visit pulp regeneration
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Necrosis focused on measuring Regeneration, mature teeth, regenerative procedures
Eligibility Criteria
Inclusion Criteria:
Single canal anterior tooth
- Mature root
- Non vital with radiographic evidence of periapical lesion
- Periapical lesion of average size 2-5mm
- Positive patient compliance for participation in the study.
- Patients with good oral hygiene
- Normal periodontal probing depth ≤ 3 mm
Exclusion Criteria:
- Compromised remaining tooth structure that need post and core build up
- Non restorable teeth
- Vital teeth
- Radiographic evidence of external or internal root resorption.
- Roots showing fracture or ankylosis
- Medically compromised patients
- Pregnant women
- Greater than grade I mobility or periodontal probing depth greater than 3mm
- Immature tooth
- Patients with pain, swelling or fistula tracts
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single visit pulp regeneration
Two visit pulp regeneration
Arm Description
Regenerative endodontic procedure not involving placement of intracanal medicament will be done in single visit
Regenerative endodontic procedure involving placing intracanal medicament will be done in two visit
Outcomes
Primary Outcome Measures
Change in Post operative pain: NRS
absence of pain reported by the patient by numerical rate scale, the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Change in swelling and/or sinus
The presence of swelling or sinus will be reported by a binary question yes/no
Periapical healing
The existing periapical lesion will be measured by mm by CBCT before intiation of treatment and after one year
Secondary Outcome Measures
Antimicrobial effect
intracanal bacterial count by culture method
Sensitivity
Tooth giving respond to electrical pulp tester
Discoloration
Recording tooth shade before and after treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03717337
Brief Title
Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth
Official Title
Evaluation of Success Rate of Non Vital Mature Anterior Teeth With Periapical Lesion Following Single Versus Two Visit Regenerative Treatment Protocol A Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates success rate of non vital mature anterior teeth with periapical lesion treated by regenerative endodontic protocol in single visit versus two visit technique.
Patients are randomized into two groups where treatment will be done either in one visit including access, disinfection, placing platelet rich plasma as scaffold and restoration or two visit protocol involving access, disinfection and placing calcium hydroxide as intracanal medicament in first visit followed by a second visit after 3 weeks involving reopening of the tooth, removing intracanal medicament and placing platelet rich plasma as scaffold then restoration. Success rate is defined as absence of subjective signs and symptoms along with healing of periapical lesion
Detailed Description
Title: Evaluation of Success Rate of Non Vital Mature Anterior Teeth with Periapical Lesion Following Single versus Two Visit Regenerative Treatment Protocol (A Randomized Clinical Trial) Regenerative endodontics can be defined as biologically based procedures designed to replace damaged structures, including dentin and root structures, as well as cells of the pulp-dentin complex.
The majority of endodontic patients are adults, thus the application of the tissue engineering concept to mature teeth could provide a biological treatment modality instead of the conventional one. In fact, several advantages were reported about regenerative procedures in well developed mature teeth. Reconstitution of the neurovascular system in root canals by pulp regeneration will provide pulp tissues with an immune system, which will function as the first line of defense against microbial challenge. Moreover, restoration of pulp dentine complex will protect the tooth during loading and mastication.
Different treatment protocols for pulp regeneration were reported in the literature regarding irrigation (type, concentration and time), intracanal medication, pulpal space barrier, incorporation and lack of scaffolds (blood clot, PRP,PRF, collagen) as well as recall visits.
Rationale for conducting the research and choice of comparators:
Multiple visits protocol has been the commonly used technique in regenerative endodontic procedures. It involves the placement of intracanal medicaments between visits (calcium hydroxide and triple antibiotic paste) which have many drawbacks such as difficulty in removal, tooth discoloration, weakening of the root and tooth loss.
Completing revascularization in one visit has many advantages. First, it reduces the chance of additional bacterial contamination of the space. Second, a single revascularization protocol may overcome the problem of poor patient compliance and reduce the number of appointments needed. Third, it can help to combat potential injury of the tooth and tooth discoloration Unfortunately, up till the moment it is not clear which protocol is the most effective. Thus randomized clinical trials are required to provide plausible answers to this question In the present research the recent single visit regenerative treatment for necrotic mature teeth will be compared to the conventionally used two visit one
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necrosis, Periapical Lesion, Anterior Teeth
Keywords
Regeneration, mature teeth, regenerative procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The design of this randomized clinical trial is a parallel group two arms trial with 1:1 allocation ratio
Masking
Outcomes Assessor
Masking Description
single
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single visit pulp regeneration
Arm Type
Experimental
Arm Description
Regenerative endodontic procedure not involving placement of intracanal medicament will be done in single visit
Arm Title
Two visit pulp regeneration
Arm Type
Active Comparator
Arm Description
Regenerative endodontic procedure involving placing intracanal medicament will be done in two visit
Intervention Type
Procedure
Intervention Name(s)
Single visit pulp regeneration
Intervention Description
Access cavity, disinfection, preparing and injecting platelet rich plasma, and restoring the tooth all done in one visit.
Intervention Type
Procedure
Intervention Name(s)
Two visit pulp regeneration
Intervention Description
first visit : access, disinfection and placing calcium hydroxide as intracanal medicament second visit: re opening of tooth, preparing and injecting platelet rich plasma and restoring the tooth.
Primary Outcome Measure Information:
Title
Change in Post operative pain: NRS
Description
absence of pain reported by the patient by numerical rate scale, the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
3, 6, 9 and 12 months
Title
Change in swelling and/or sinus
Description
The presence of swelling or sinus will be reported by a binary question yes/no
Time Frame
3,6,9,12 months
Title
Periapical healing
Description
The existing periapical lesion will be measured by mm by CBCT before intiation of treatment and after one year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Antimicrobial effect
Description
intracanal bacterial count by culture method
Time Frame
before and after complete disinfection either in the same visit or after 3 weeks from the second visit
Title
Sensitivity
Description
Tooth giving respond to electrical pulp tester
Time Frame
3, 6, 9 and 12 months
Title
Discoloration
Description
Recording tooth shade before and after treatment
Time Frame
3, 6, 9 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Single canal anterior tooth
Mature root
Non vital with radiographic evidence of periapical lesion
Periapical lesion of average size 2-5mm
Positive patient compliance for participation in the study.
Patients with good oral hygiene
Normal periodontal probing depth ≤ 3 mm
Exclusion Criteria:
Compromised remaining tooth structure that need post and core build up
Non restorable teeth
Vital teeth
Radiographic evidence of external or internal root resorption.
Roots showing fracture or ankylosis
Medically compromised patients
Pregnant women
Greater than grade I mobility or periodontal probing depth greater than 3mm
Immature tooth
Patients with pain, swelling or fistula tracts
12. IPD Sharing Statement
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Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth
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