Pulp NecrosisNCT03717337
Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth
A study testing Single visit pulp regeneration and Two visit pulp regeneration in people with Pulp Necrosis and Periapical Lesion, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necrosis, Periapical Lesion, Anterior Teeth
- What is being tested?
- Single visit pulp regeneration and Two visit pulp regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnant women
- Greater than grade I mobility or periodontal probing depth greater than 3mm
- Immature tooth
- Patients with pain, swelling or fistula tracts
About this study
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
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
Read the 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
- Conditions
- Pulp Necrosis, Periapical Lesion, Anterior Teeth
- Being tested
- Single visit pulp regeneration, Two visit pulp regeneration
- Keywords
- Regeneration, mature teeth, regenerative procedures
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single visit pulp regenerationProcedure or surgery
Access cavity, disinfection, preparing and injecting platelet rich plasma, and restoring the tooth all done in one visit.
Two visit pulp regenerationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single visit pulp regeneration | Experimental | Regenerative endodontic procedure not involving placement of intracanal medicament will be done in single visit Receives: Procedure: Single visit pulp regeneration |
| Two visit pulp regeneration | Active comparator | Regenerative endodontic procedure involving placing intracanal medicament will be done in two visit Receives: Procedure: Two visit pulp regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 3, 6, 9 and 12 months
Change in swelling and/or sinus
The presence of swelling or sinus will be reported by a binary question yes/no
Measured: 3,6,9,12 months
Periapical healing
The existing periapical lesion will be measured by mm by CBCT before intiation of treatment and after one year
Measured: 12 months
Secondary outcomes (3)
Antimicrobial effect
intracanal bacterial count by culture method
Measured: before and after complete disinfection either in the same visit or after 3 weeks from the second visit
Sensitivity
Tooth giving respond to electrical pulp tester
Measured: 3, 6, 9 and 12 months
Discoloration
Recording tooth shade before and after treatment
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design of this randomized clinical trial is a parallel group two arms trial with 1:1 allocation ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lamiaa Mohamed Ragaei Lasheen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717337
- Sponsor's protocol ID
- Faculty of dentistry 2018
- Status last verified
- Oct 2018
- First submitted
- 14 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lasheen LR, Gawdat SI, Lutfy RA. Success Rate of Single Versus Two-Visit Regenerative Treatment Protocol in Non-Vital Mature Anterior Teeth (A Preliminary Randomised Clinical Trial). Aust Endod J. 2025 Aug;51(2):308-316. doi: 10.1111/aej.12943. Epub 2025 Apr 11.
PubMed 40219648
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03717337
- Acronym / sponsor ID
- Faculty of dentistry 2018
- Conditions
- Pulp Necrosis, Periapical Lesion, Anterior Teeth
- Keywords
- Regeneration, mature teeth, regenerative procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design of this randomized clinical trial is a parallel group two arms trial with 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Single visit pulp regeneration | Experimental | Procedure: Single visit pulp regenerationRegenerative endodontic procedure not involving placement of intracanal medicament will be done in single visit |
| Two visit pulp regeneration | Active comparator | Procedure: Two visit pulp regenerationRegenerative endodontic procedure involving placing intracanal medicament will be done in two visit |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Single canal anterior tooth
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single visit pulp regenerationAccess cavity, disinfection, preparing and injecting platelet rich plasma, and restoring the tooth all done in one visit. | Procedure or surgery | Single visit pulp regeneration |
| Two visit pulp regenerationfirst 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. | Procedure or surgery | Two visit pulp regeneration |
Primary outcome
Change in Post operative pain: NRS
Time frame: 3, 6, 9 and 12 months
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
Time frame: 3,6,9,12 months
The presence of swelling or sinus will be reported by a binary question yes/no
Periapical healing
Time frame: 12 months
The existing periapical lesion will be measured by mm by CBCT before intiation of treatment and after one year
3 secondary outcomes
Antimicrobial effect
Time frame: before and after complete disinfection either in the same visit or after 3 weeks from the second visit
Sensitivity
Time frame: 3, 6, 9 and 12 months
Discoloration
Time frame: 3, 6, 9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Derived from this study: PubMed 40219648Lasheen LR, Gawdat SI, Lutfy RA. Success Rate of Single Versus Two-Visit Regenerative Treatment Protocol in Non-Vital Mature Anterior Teeth (A Preliminary Randomised Clinical Trial). Aust Endod J. 2025 Aug;51(2):308-316. doi: 10.1111/aej.12943. Epub 2025 Apr 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Single visit pulp regeneration and Two visit pulp regeneration in people with Pulp Necrosis and Periapical Lesion, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post operative pain: NRS (time frame: 3, 6, 9 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03717337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.