Attachment LossNCT02630745
Immediate Verses Delayed Surgical Periodontal Therapy After Endodontic Treatment in Endo Perio Lesion With Communication
A study testing Immediate periodontal surgery and Delayed periodontal surgery in people with Attachment Loss and Tooth,Non Vital, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial summary
The aim of the study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment on periodontal healing of the concurrent endodontic -periodontal lesion with communication. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Attachment Loss, Tooth,Non Vital
- What is being tested?
- Immediate periodontal surgery and Delayed periodontal surgery
- Type of treatment
- Injection or infusion, 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
- Jun 2015to Oct 2016
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Patients of age 18 years and above with a clinical and radiographic diagnosis of combined endodontic periodontal lesion and having generalized chronic periodontitis with at least one non vital tooth having apical radiolucency with communication.
- Wide base pocket, deep pocket depth
- Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
- Radiographic periapical alveolar bone destruction with apical communication
Exclusion Criteria:• Systemic illness known to affect the periodontium or outcome of periodontal therapy.
- Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
- Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
- Pregnant or lactating mothers.
- Smokers and tobacco chewers.
- Grade 3 mobile teeth.
- Unrestorable tooth.
- Fractured/perforated roots.
- Developing permanent tooth.
- Previously root canal filled.
- History of recent periodontal treatment within 6 months prior to study.
About this study
Official title: Evaluation of the Effect of Immediate and Delayed Surgical Periodontal Therapy After Non-surgical Endodontic Treatment on Periodontal Healing in Concurrent Endodontic Periodontal Lesion With Communication-A Randomized Clinical Trial"
The aim of the study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment on periodontal healing of the concurrent endodontic -periodontal lesion with communication.
Read the detailed description
Observations based upon review articles and case reports has suggested, if the root canal system is infected, endodontic treatment should be commenced prior to any periodontal therapy in order to remove the intra canal infection before any cementum is removed in case of concurrent endodontic-periodontic lesions without communication. This avoids several complications and provides a more favourable environment for periodontal repair. Treatment results of endodontic therapy should be evaluated in 2-3 months and only then periodontal treatment should be considered. But review articles states that teeth that have concurrent endodontic and periodontal diseases that communicate with each other will require comprehensive treatment with both endodontic and periodontal management. Ideally both infections should be removed before the root canal filling and any final restorations are provided. Completion of the root canal filling should be delayed until the periodontal prognosis has been reassessed and determined following initial, and often further, periodontal treatment. Though Infected root canal systems and periodontal pockets have similar microbiological flora, there are more microbes and more species of spirochetes in periodontal pockets than in infected root canal systems, and the microflora in infected root canals of teeth that have concurrent endodontic and periodontal diseases is more complex than in teeth with infection confined to the periapical region. So the outcome of endodontic treatment may be affected if the root canal filling is placed while there is still a periodontal infection present that communicates with the root canal system since cross-seeding through the apical or lateral foramina is possible. An In-vitro study on human extracted teeth states that despite thorough cleaning and disinfection of the root canal system during endodontic treatment, bacteria from the periodontal lesion may re-invade the root canal system since root canal fillings do not seal canals completely.
All the above findings are based on microbiological,histological,case-reports,retrospective and in-vitro studies.The timing of periodontal treatment in concurrent endodontic -periodontal lesions with communication still remains a issue of debate.No prospective human clinical trial(randomized) has been conducted till date to ascertain whether surgical periodontal treatment should be given immediately after completion of non-surgical endodontic treatment or 2-3 months after completion of non-surgical endodontic treatment.
Thus the aim of our study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment for the management of concurrent endodontic -periodontal lesion with communication.
MATERIAL AND METHOD This randomized clinical trial will be conducted in Department of Periodontics and Oral Implantology in collaboration with Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak.
STUDY POPULATION Patients were recruited from regular out patient department of the department of periodontics and oral implantology,department of conservative dentistry and endodontics and department of oral medicine, diagnosis and radiology. The study will be conducted as follows:-
- Immediate surgery group Treatment involves surgical periodontal therapy in form of open flap debridement immediately after non-surgical endodontic treatment.
- Delayed surgery group Treatment involves surgical periodontal therapy in form of open flap debridement 3 months after completion of non-surgical endodontic treatment. INCLUSION CRITERIA Patients of age 18 years and above with a clinical and radiographic diagnosis of combined endodontic periodontal lesion and having generalized chronic periodontitis with at least one non vital tooth having apical radiolucency with communication.
- Wide base pocket, deep pocket depth
- Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
- Radiographic periapical alveolar bone destruction with apical communication
- Patients having generalized chronic periodontitis [≥2 interproximal sites with clinical attachment level (CAL) ≥ 4mm,not on same tooth(moderate) or ≥2 interproximal sites with clinical attachment level (CAL)≥6mm ,not on same tooth (severe)]26
EXCLUSION CRITERIA
- Systemic illness known to affect the periodontium or outcome of periodontal therapy.
- Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
- Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
- Pregnant or lactating mothers.
- Smokers and tobacco chewers.
- Grade 3 mobile teeth.
- Unrestorable tooth.
- Fractured/perforated roots.
- Developing permanent tooth.
- Previously root canal filled.
- History of recent periodontal treatment within 6 months prior to study.
Prior informed consent will be taken from each patient after explaining the procedure in patient's language along with risk and benefits involved.
METHODOLOGY Patients were randomly allocated to group1 and group 2. The study will be conducted as follows:-
- Presurgical therapy:- which will be including
- Oral hygiene instructions
- Full mouth supragingival and subgingival scaling and root planning with ultrasonic scaler, hand scaler and curettes.
- Conventional root canal therapy will be initiated in both the groups before definite periodontal surgical therapy.
- Surgical therapy:- In group 1 periodontal surgical procedure in the form of open flap debridement will be performed immediately after obturation of the root canal system In group 2 periodontal surgical procedure in the form of open flap debridement will be performed 3 months after obturation of the root canal system Prior to surgery, a probing stent will be fabricated for every patient,relative to which attachment loss will be measured.
CLINICAL PARAMETERS
- Full mouth indices to be recorded at baseline
- Bleeding on probing
- Probing Pocket depth
- Attachment loss
- Site specific indices
- Plaque index
- Gingival index
- Relative Probing Pocket depth
- Relative attachment loss
- Bleeding on probing
- Tooth mobility
- Relative gingival marginal level Using periodontal probe at 6 sites (mesial, distal, median points at buccal and lingual aspects) per tooth.
Customized bite blocks and parallel angle technique will be used to obtain radiographs Clinical parameters will be recorded at baseline, 3 months and 6 months for Group 1(immediate surgery) Clinical parameters will be recorded at baseline, 3 months, 6 months and 9 months for Group 2(delayed surgery) PERIODONTAL PROCEDURE This involves supragingival and subgingival scaling and root planning to be performed with ultrasonic scaler, hand scaler and curette and will be completed in minimum two sessions.
CONVENTIONAL ENDODONTIC PROCEDURE After achieving local anaesthesia, access opening will be made with the help of round bur. Then the root canal will be thoroughly debrided followed by copious irrigation and subsequently prepared with the help of endo files. After preparation of the canal, calcium hydroxide intracanal medicament will be placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer. Obturation will be performed with gutta percha and zinc oxide eugenol based sealer.
PERIODONTAL SURGICAL PROCEDURE After administration of local anaesthesia, buccal and lingual/palatal intracrevicular incision will be made and mucoperiosteal flaps will be reflected including atleast one tooth ahead and another behind the tooth. Meticulous defect debridement and root planning will be carried out using area specific curettes and scalers with special effort to remove all the granulation tissue. After instrumentation, the root surfaces will be washed with saline solution in attempt to remove any remaining detached fragments from the defect and surgical field. After debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture. The surgical area will be protected and covered with periodontal dressing and post operative instructions will be given.
Processing of Data Data recorded will be processed by standard statistical analysis.
- Conditions
- Attachment Loss, Tooth,Non Vital
- Being tested
- Immediate periodontal surgery, Delayed periodontal surgery
- Keywords
- endodontic treatment, open flap debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate periodontal surgeryProcedure or surgery
Treatment involves immediate surgical periodontal therapy in form of open flap debridement after non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in concurrent endodontic periodontal lesions with communication .
Delayed periodontal surgeryProcedure or surgery
Treatment involves surgical periodontal therapy after 3 months of non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in the form of open flap debridement in concurrent endodontic periodontal lesions with communication .
| Study group | Role | What they receive |
|---|---|---|
| Immediate periodontal surgery (Group 1) | Active comparator | periodontal surgical procedure in the form of open flap debridement will be performed immediately( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) after obturation of the root canal system( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer). Receives: Procedure: Immediate periodontal surgery |
| Delayed periodontal surgery (Group 2) | Active comparator | periodontal surgical procedure in the form of open flap debridement( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) will be performed 3 months after obturation of the root canal system ( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer). Receives: Procedure: Delayed periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Attachment Loss
measurement done by periodontal probe with stents
Measured: 6 months in group 1, 9 months in group 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attachment LossStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630745
- Sponsor's protocol ID
- Perio 2
- Status last verified
- Dec 2015
- First submitted
- 8 Dec 2015
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Immediate and Delayed Surgical Periodontal Therapy After Non-surgical Endodontic Treatment on Periodontal Healing in Concurrent Endodontic Periodontal Lesion With Communication-A Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT02630745
- Acronym / sponsor ID
- Perio 2
- Conditions
- Attachment Loss, Tooth,Non Vital
- Keywords
- endodontic treatment, open flap debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Dec 2015 (estimated)
- 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.
The aim of the study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment on periodontal healing of the concurrent endodontic -periodontal lesion with communication.
Detailed description
Observations based upon review articles and case reports has suggested, if the root canal system is infected, endodontic treatment should be commenced prior to any periodontal therapy in order to remove the intra canal infection before any cementum is removed in case of concurrent endodontic-periodontic lesions without communication. This avoids several complications and provides a more favourable environment for periodontal repair. Treatment results of endodontic therapy should be evaluated in 2-3 months and only then periodontal treatment should be considered. But review articles states that teeth that have concurrent endodontic and periodontal diseases that communicate with each other will require comprehensive treatment with both endodontic and periodontal management. Ideally both infections should be removed before the root canal filling and any final restorations are provided. Completion of the root canal filling should be delayed until the periodontal prognosis has been reassessed and determined following initial, and often further, periodontal treatment. Though Infected root canal systems and periodontal pockets have similar microbiological flora, there are more microbes and more species of spirochetes in periodontal pockets than in infected root canal systems, and the microflora in infected root canals of teeth that have concurrent endodontic and periodontal diseases is more complex than in teeth with infection confined to the periapical region. So the outcome of endodontic treatment may be affected if the root canal filling is placed while there is still a periodontal infection present that communicates with the root canal system since cross-seeding through the apical or lateral foramina is possible. An In-vitro study on human extracted teeth states that despite thorough cleaning and disinfection of the root canal system during endodontic treatment, bacteria from the periodontal lesion may re-invade the root canal system since root canal fillings do not seal canals completely.
All the above findings are based on microbiological,histological,case-reports,retrospective and in-vitro studies.The timing of periodontal treatment in concurrent endodontic -periodontal lesions with communication still remains a issue of debate.No prospective human clinical trial(randomized) has been conducted till date to ascertain whether surgical periodontal treatment should be given immediately after completion of non-surgical endodontic treatment or 2-3 months after completion of non-surgical endodontic treatment.
Thus the aim of our study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment for the management of concurrent endodontic -periodontal lesion with communication.
MATERIAL AND METHOD This randomized clinical trial will be conducted in Department of Periodontics and Oral Implantology in collaboration with Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak.
STUDY POPULATION Patients were recruited from regular out patient department of the department of periodontics and oral implantology,department of conservative dentistry and endodontics and department of oral medicine, diagnosis and radiology. The study will be conducted as follows:-
- Immediate surgery group Treatment involves surgical periodontal therapy in form of open flap debridement immediately after non-surgical endodontic treatment.
- Delayed surgery group Treatment involves surgical periodontal therapy in form of open flap debridement 3 months after completion of non-surgical endodontic treatment. INCLUSION CRITERIA Patients of age 18 years and above with a clinical and radiographic diagnosis of combined endodontic periodontal lesion and having generalized chronic periodontitis with at least one non vital tooth having apical radiolucency with communication.
- Wide base pocket, deep pocket depth
- Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
- Radiographic periapical alveolar bone destruction with apical communication
- Patients having generalized chronic periodontitis [≥2 interproximal sites with clinical attachment level (CAL) ≥ 4mm,not on same tooth(moderate) or ≥2 interproximal sites with clinical attachment level (CAL)≥6mm ,not on same tooth (severe)]26
EXCLUSION CRITERIA
- Systemic illness known to affect the periodontium or outcome of periodontal therapy.
- Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
- Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
- Pregnant or lactating mothers.
- Smokers and tobacco chewers.
- Grade 3 mobile teeth.
- Unrestorable tooth.
- Fractured/perforated roots.
- Developing permanent tooth.
- Previously root canal filled.
- History of recent periodontal treatment within 6 months prior to study.
Prior informed consent will be taken from each patient after explaining the procedure in patient's language along with risk and benefits involved.
METHODOLOGY Patients were randomly allocated to group1 and group 2. The study will be conducted as follows:-
- Presurgical therapy:- which will be including
- Oral hygiene instructions
- Full mouth supragingival and subgingival scaling and root planning with ultrasonic scaler, hand scaler and curettes.
- Conventional root canal therapy will be initiated in both the groups before definite periodontal surgical therapy.
- Surgical therapy:- In group 1 periodontal surgical procedure in the form of open flap debridement will be performed immediately after obturation of the root canal system In group 2 periodontal surgical procedure in the form of open flap debridement will be performed 3 months after obturation of the root canal system Prior to surgery, a probing stent will be fabricated for every patient,relative to which attachment loss will be measured.
CLINICAL PARAMETERS
- Full mouth indices to be recorded at baseline
- Bleeding on probing
- Probing Pocket depth
- Attachment loss
- Site specific indices
- Plaque index
- Gingival index
- Relative Probing Pocket depth
- Relative attachment loss
- Bleeding on probing
- Tooth mobility
- Relative gingival marginal level Using periodontal probe at 6 sites (mesial, distal, median points at buccal and lingual aspects) per tooth.
Customized bite blocks and parallel angle technique will be used to obtain radiographs Clinical parameters will be recorded at baseline, 3 months and 6 months for Group 1(immediate surgery) Clinical parameters will be recorded at baseline, 3 months, 6 months and 9 months for Group 2(delayed surgery) PERIODONTAL PROCEDURE This involves supragingival and subgingival scaling and root planning to be performed with ultrasonic scaler, hand scaler and curette and will be completed in minimum two sessions.
CONVENTIONAL ENDODONTIC PROCEDURE After achieving local anaesthesia, access opening will be made with the help of round bur. Then the root canal will be thoroughly debrided followed by copious irrigation and subsequently prepared with the help of endo files. After preparation of the canal, calcium hydroxide intracanal medicament will be placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer. Obturation will be performed with gutta percha and zinc oxide eugenol based sealer.
PERIODONTAL SURGICAL PROCEDURE After administration of local anaesthesia, buccal and lingual/palatal intracrevicular incision will be made and mucoperiosteal flaps will be reflected including atleast one tooth ahead and another behind the tooth. Meticulous defect debridement and root planning will be carried out using area specific curettes and scalers with special effort to remove all the granulation tissue. After instrumentation, the root surfaces will be washed with saline solution in attempt to remove any remaining detached fragments from the defect and surgical field. After debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture. The surgical area will be protected and covered with periodontal dressing and post operative instructions will be given.
Processing of Data Data recorded will be processed by standard statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate periodontal surgery (Group 1) | Active comparator | Procedure: Immediate periodontal surgeryperiodontal surgical procedure in the form of open flap debridement will be performed immediately( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) after obturation of the root canal system( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer). |
| Delayed periodontal surgery (Group 2) | Active comparator | Procedure: Delayed periodontal surgeryperiodontal surgical procedure in the form of open flap debridement( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) will be performed 3 months after obturation of the root canal system ( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Immediate periodontal surgeryTreatment involves immediate surgical periodontal therapy in form of open flap debridement after non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in concurrent endodontic periodontal lesions with communication . | Procedure or surgery | Immediate periodontal surgery (Group 1) |
| Delayed periodontal surgeryTreatment involves surgical periodontal therapy after 3 months of non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in the form of open flap debridement in concurrent endodontic periodontal lesions with communication . | Procedure or surgery | Delayed periodontal surgery (Group 2) |
Primary outcome
Relative Attachment Loss
Time frame: 6 months in group 1, 9 months in group 2
measurement done by periodontal probe with stents
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
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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 Immediate periodontal surgery and Delayed periodontal surgery in people with Attachment Loss and Tooth,Non Vital, run by Postgraduate Institute of Dental Sciences Rohtak.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 26 Sep 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative Attachment Loss (time frame: 6 months in group 1, 9 months in group 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2017.