Periapical PeriodontitisNCT05719987
Biodentine as an Apical Plug in Immature Permanent Molars
A study testing Biodentine and MTA in people with Periapical Periodontitis, run by Damascus University at 1 site in Syria.
Trial summary
Following the randomization procedure, patients will be divided into 2 groups (12 immature molars in each group): Group I will be treated with MTA as apical plug, whereas group II will be treated with Biodentine as apical plug. Read more about this study
- Who is it for?
- Ages 8 to 9 years
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Biodentine and MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2020to 30 Apr 2021
- 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 8 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cooperative children.
- Healthy children without any systemic disease or compromised immune status.
- Children with first immature mandibular molar with at least one canal sized #60 or more with an apical lesion.
Who cannot join
- Patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss).
- Molars that cannot be restored (root fracture, unrestorable tooth, massive internal or external).
- Molars that had previous endodontic treatment.
Trial locations and contacts
1 site in 1 country.
Syria1 site
College of dentistry.
Damascus, Al-Mazzeh Saint, Damascus P.O.Box 3062
About this study
Official title: Effect of Biodentine Application as an Apical Plug on the Healing of Apical Lesions on Immature Permanent Molars.
Following the randomization procedure, patients will be divided into 2 groups (12 immature molars in each group): Group I will be treated with MTA as apical plug, whereas group II will be treated with Biodentine as apical plug. After working length determination, instrumentation and sterilizing root canals, apical plug will be done as following:
Biodentine Group: Biodentine will be placed into the apical portion of canals. After 12 min the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown.
Read more
MTA Group: MTA will be placed into the apical portion of canals, then a moist cotton pellet will be placed and the access cavity will be restored with temporary filling. Next day, temporary filling and the cotton pellet will be removed, then the coronal restoration will be performed as Biodentine group.
Patients of both groups will be recalled for clinical and radiographical follow-up within 12 months after treatment.
Read the detailed description
Following the randomization procedure, patients will be assigned sequential numbers in the order of enrolment. Group I will include 12 immature molars treated with MTA (White ProRoot MTA, Dentsply, Tulsa, OK, USA) as apical plug, whereas group II will include 12 immature molars treated with Biodentine (Septodont, Saint-Maur-des-Fosses, France) as apical plug. All the apexification treatments will be performed by the researcher. Under local anesthesia and rubber dam isolation, all superficial caries will be removed with carbide fissure bur mounted on a low-speed hand-piece. Access cavity will be prepared using an endo-z bur mounted on high-speed hand-piece, and the cavity will be rinsed with 2.5% NaOCl. Working length will be calculated radiographically with K-files (Mani, INK, Japan) and recorded as reference. root canals will be instrumented gently with Fanta AF3 (Fanta Dental Materials Co., LTD, Shanghai, China) and copious irrigation with 1.3% sodium hypochlorite (NaOCI) (Merck, Darmstadt, Germany) by a 30- gauge endodontic irrigating needle (Sybron Endo, Crop, Orange, CA, USA). As final irrigation all canals will be filled up with NaOCl 1.3% and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 30 seconds for each canal, then all canals will be irrigated with normal saline, then all canals will be filled up with Q-mix (Dentsply Tulsa Dental, Tulsa, OK, USA) and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 10 seconds. After drying with large sterile paper points apical plug will be done according to randomization MTA with 2 visits or Biodentine with one visit.
Biodentine Group (performed in a single clinic visit of approximately 45 minutes): Biodentine will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the Biodentine plugs will be verified with a radiograph. After 12 min the setting of Biodentine will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless-steel crown (3M ESPE, Dental Products, St. Paul, MN, USA).
MTA Group (performed in 2 clinic visits, each visit will be approximately 30 minutes): MTA will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the MTA plugs will be verified with a radiograph. After inserting MTA, a moist cotton pellet will be placed in the canal, and the access cavity will be restored with temporary filling (TG, Germany). Next day, under local anesthesia and rubber dam isolation, the temporary filling and the cotton pellet will be removed and the setting of MTA will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless steel crown (3M ESPE, Dental Products, St. Paul, MN, USA).
Patients of both groups will be recalled for radiographical follow-up after the end of treatment at 1, 3, 6 and 12 months. Periapical radiographs will be obtained under standard exposure conditions (60 kVp, 7 mA and 0.32 s) using a dental X-ray machine (Gendex GX, Lake Zurich, IL, USA) and intraoral sensor (VATECH. Gyeonggi-do, Korea) . The radiographic assessment will be done with two pre-trained independent investigators. Each investigator will determine the size of apical lesion using "Image J" program and scored in both groups blindly, independently and will repeat the radiographic scoring after 1 month to assess the intraobserver reliability. Any disagreement on apical lesion size for a particular root resulted in joint evaluation until agreement will be reached.
Patients of both groups will be recalled for clinical follow-up after the end of treatment at 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months to detect pain, swelling, tenderness to percussion, abscess, fistula, and abnormal tooth mobility Finally, the numerical data of the apical lesions sizes and ranked data of clinical variables will be statistically analyzed using SPSS, and any statistically significant values will be investigated.
- Conditions
- Periapical Periodontitis
- Being tested
- Biodentine, MTA
- Keywords
- Apexification, MTA, Biodentine, Immature molars
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineOther
After the endodontic procedure, Biodentine will be placed into the apical portion of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown.
MTAOther
After the endodontic procedure, MTA will be placed into the apical portion of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine Group | Experimental | study group Receives: Other: Biodentine |
| MTA Group | Other | control group Receives: Other: MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the apical lesion size
The apexification procedure was judged to be radiographically successful if it demonstrated the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption.
The apexification procedure was judged to be radiographically unsuccessful if the apical lesion size increased.
The apexification procedure was judged to be doubtful if the apical lesion size didn't change
Measured: after 1,3,6 and 12 months of root canal obturation
Change in the clinical assessment of success
The apexification procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Measured: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months of root canal obturation
Secondary outcomes (2)
Change in the apical lesion healing speed
Apical lesion healing speed of MTA apical plugs and Biodentine apical plugs in necrotic immature permanent molars with apical lesions using "Image J" to determine the percentage of apical lesion reduction
Measured: after 1,3,6 and 12 months of root canal obturation
Change in the periapical index (PAI)
Radio-graphically, the periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss. (4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).
Measured: after 1,3,6 and 12 months of root canal obturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Jan 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- 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
- Randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chaza Kouchaji, Professor, Study director, supervisalThuraya Lazkani, Professor, Study director, co-supervisal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719987
- Sponsor's protocol ID
- UDDS-Pedo-12-2016
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pace R, Giuliani V, Pini Prato L, Baccetti T, Pagavino G. Apical plug technique using mineral trioxide aggregate: results from a case series. Int Endod J. 2007 Jun;40(6):478-84. doi: 10.1111/j.1365-2591.2007.01240.x.
PubMed 17403040Kandemir Demirci G, Kaval ME, Guneri P, Caliskan MK. Treatment of immature teeth with nonvital pulps in adults: a prospective comparative clinical study comparing MTA with Ca(OH)2. Int Endod J. 2020 Jan;53(1):5-18. doi: 10.1111/iej.13201. Epub 2019 Sep 3.
PubMed 31397907Alsayed Tolibah Y, Kouchaji C, Lazkani T, Abbara MT, Jbara S, Baghdadi ZD. Dental Care for a Child with Congenital Hydrocephalus: A Case Report with 12-Month Follow-Up. Int J Environ Res Public Health. 2021 Jan 29;18(3):1209. doi: 10.3390/ijerph18031209.
PubMed 33572890Vidal K, Martin G, Lozano O, Salas M, Trigueros J, Aguilar G. Apical Closure in Apexification: A Review and Case Report of Apexification Treatment of an Immature Permanent Tooth with Biodentine. J Endod. 2016 May;42(5):730-4. doi: 10.1016/j.joen.2016.02.007. Epub 2016 Mar 16.
PubMed 26994597Ajram J, Khalil I, Gergi R, Zogheib C. Management of an Immature Necrotic Permanent Molar with Apical Periodontitis Treated by Regenerative Endodontic Protocol Using Calcium Hydroxide and MM-MTA: A Case Report with Two Years Follow Up. Dent J (Basel). 2019 Jan 1;7(1):1. doi: 10.3390/dj7010001.
PubMed 30609673Khetarpal A, Chaudhary S, Talwar S, Verma M. Endodontic management of open apex using Biodentine as a novel apical matrix. Indian J Dent Res. 2014 Jul-Aug;25(4):513-6. doi: 10.4103/0970-9290.142555.
PubMed 25307919
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biodentine Application as an Apical Plug on the Healing of Apical Lesions on Immature Permanent Molars.
- ClinicalTrials.gov ID
- NCT05719987
- Acronym / sponsor ID
- UDDS-Pedo-12-2016
- Conditions
- Periapical Periodontitis
- Keywords
- Apexification, MTA, Biodentine, Immature molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 9 Feb 2023 (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.
Following the randomization procedure, patients will be divided into 2 groups (12 immature molars in each group): Group I will be treated with MTA as apical plug, whereas group II will be treated with Biodentine as apical plug. After working length determination, instrumentation and sterilizing root canals, apical plug will be done as following:
Biodentine Group: Biodentine will be placed into the apical portion of canals. After 12 min the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown.
MTA Group: MTA will be placed into the apical portion of canals, then a moist cotton pellet will be placed and the access cavity will be restored with temporary filling. Next day, temporary filling and the cotton pellet will be removed, then the coronal restoration will be performed as Biodentine group.
Patients of both groups will be recalled for clinical and radiographical follow-up within 12 months after treatment.
Detailed description
Following the randomization procedure, patients will be assigned sequential numbers in the order of enrolment. Group I will include 12 immature molars treated with MTA (White ProRoot MTA, Dentsply, Tulsa, OK, USA) as apical plug, whereas group II will include 12 immature molars treated with Biodentine (Septodont, Saint-Maur-des-Fosses, France) as apical plug. All the apexification treatments will be performed by the researcher. Under local anesthesia and rubber dam isolation, all superficial caries will be removed with carbide fissure bur mounted on a low-speed hand-piece. Access cavity will be prepared using an endo-z bur mounted on high-speed hand-piece, and the cavity will be rinsed with 2.5% NaOCl. Working length will be calculated radiographically with K-files (Mani, INK, Japan) and recorded as reference. root canals will be instrumented gently with Fanta AF3 (Fanta Dental Materials Co., LTD, Shanghai, China) and copious irrigation with 1.3% sodium hypochlorite (NaOCI) (Merck, Darmstadt, Germany) by a 30- gauge endodontic irrigating needle (Sybron Endo, Crop, Orange, CA, USA). As final irrigation all canals will be filled up with NaOCl 1.3% and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 30 seconds for each canal, then all canals will be irrigated with normal saline, then all canals will be filled up with Q-mix (Dentsply Tulsa Dental, Tulsa, OK, USA) and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 10 seconds. After drying with large sterile paper points apical plug will be done according to randomization MTA with 2 visits or Biodentine with one visit.
Biodentine Group (performed in a single clinic visit of approximately 45 minutes): Biodentine will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the Biodentine plugs will be verified with a radiograph. After 12 min the setting of Biodentine will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless-steel crown (3M ESPE, Dental Products, St. Paul, MN, USA).
MTA Group (performed in 2 clinic visits, each visit will be approximately 30 minutes): MTA will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the MTA plugs will be verified with a radiograph. After inserting MTA, a moist cotton pellet will be placed in the canal, and the access cavity will be restored with temporary filling (TG, Germany). Next day, under local anesthesia and rubber dam isolation, the temporary filling and the cotton pellet will be removed and the setting of MTA will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless steel crown (3M ESPE, Dental Products, St. Paul, MN, USA).
Patients of both groups will be recalled for radiographical follow-up after the end of treatment at 1, 3, 6 and 12 months. Periapical radiographs will be obtained under standard exposure conditions (60 kVp, 7 mA and 0.32 s) using a dental X-ray machine (Gendex GX, Lake Zurich, IL, USA) and intraoral sensor (VATECH. Gyeonggi-do, Korea) . The radiographic assessment will be done with two pre-trained independent investigators. Each investigator will determine the size of apical lesion using "Image J" program and scored in both groups blindly, independently and will repeat the radiographic scoring after 1 month to assess the intraobserver reliability. Any disagreement on apical lesion size for a particular root resulted in joint evaluation until agreement will be reached.
Patients of both groups will be recalled for clinical follow-up after the end of treatment at 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months to detect pain, swelling, tenderness to percussion, abscess, fistula, and abnormal tooth mobility Finally, the numerical data of the apical lesions sizes and ranked data of clinical variables will be statistically analyzed using SPSS, and any statistically significant values will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Biodentine Group | Experimental | Other: Biodentinestudy group |
| MTA Group | Other | Other: MTAcontrol group |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cooperative children.
- Healthy children without any systemic disease or compromised immune status.
- Children with first immature mandibular molar with at least one canal sized #60 or more with an apical lesion.
Key exclusion criteria (3 listed)
- Patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss).
- Molars that cannot be restored (root fracture, unrestorable tooth, massive internal or external).
- Molars that had previous endodontic treatment.
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 |
|---|---|---|
| BiodentineAfter the endodontic procedure, Biodentine will be placed into the apical portion of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown. | Other | Biodentine Group |
| MTAAfter the endodontic procedure, MTA will be placed into the apical portion of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha and AH Plus. The coronal restoration will be completed with GIC, composite, and stainless-steel crown. | Other | MTA Group |
Primary outcome
Change in the apical lesion size
Time frame: after 1,3,6 and 12 months of root canal obturation
The apexification procedure was judged to be radiographically successful if it demonstrated the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption. The apexification procedure was judged to be radiographically unsuccessful if the apical lesion size increased. The apexification procedure was judged to be doubtful if the apical lesion size didn't change
Change in the clinical assessment of success
Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months of root canal obturation
The apexification procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
2 secondary outcomes
Change in the apical lesion healing speed
Time frame: after 1,3,6 and 12 months of root canal obturation
Change in the periapical index (PAI)
Time frame: after 1,3,6 and 12 months of root canal obturation
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 14 Feb 2023.
- Background: PubMed 17403040Pace R, Giuliani V, Pini Prato L, Baccetti T, Pagavino G. Apical plug technique using mineral trioxide aggregate: results from a case series. Int Endod J. 2007 Jun;40(6):478-84. doi: 10.1111/j.1365-2591.2007.01240.x.
- Results publication: PubMed 31397907Kandemir Demirci G, Kaval ME, Guneri P, Caliskan MK. Treatment of immature teeth with nonvital pulps in adults: a prospective comparative clinical study comparing MTA with Ca(OH)2. Int Endod J. 2020 Jan;53(1):5-18. doi: 10.1111/iej.13201. Epub 2019 Sep 3.
- Results publication: PubMed 33572890Alsayed Tolibah Y, Kouchaji C, Lazkani T, Abbara MT, Jbara S, Baghdadi ZD. Dental Care for a Child with Congenital Hydrocephalus: A Case Report with 12-Month Follow-Up. Int J Environ Res Public Health. 2021 Jan 29;18(3):1209. doi: 10.3390/ijerph18031209.
- Results publication: PubMed 26994597Vidal K, Martin G, Lozano O, Salas M, Trigueros J, Aguilar G. Apical Closure in Apexification: A Review and Case Report of Apexification Treatment of an Immature Permanent Tooth with Biodentine. J Endod. 2016 May;42(5):730-4. doi: 10.1016/j.joen.2016.02.007. Epub 2016 Mar 16.
- Results publication: PubMed 30609673Ajram J, Khalil I, Gergi R, Zogheib C. Management of an Immature Necrotic Permanent Molar with Apical Periodontitis Treated by Regenerative Endodontic Protocol Using Calcium Hydroxide and MM-MTA: A Case Report with Two Years Follow Up. Dent J (Basel). 2019 Jan 1;7(1):1. doi: 10.3390/dj7010001.
- Results publication: PubMed 25307919Khetarpal A, Chaudhary S, Talwar S, Verma M. Endodontic management of open apex using Biodentine as a novel apical matrix. Indian J Dent Res. 2014 Jul-Aug;25(4):513-6. doi: 10.4103/0970-9290.142555.
- Individual participant dataSharing planned: No
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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.
Chaza Kouchaji, Professor study director
supervisal
Thuraya Lazkani, Professor study director
co-supervisal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine and MTA in people with Periapical Periodontitis, run by Damascus University at 1 site in Syria.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in the apical lesion size (time frame: after 1,3,6 and 12 months of root canal obturation). The study lists 2 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 NCT05719987, which also lists 6 linked publications.
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 14 Feb 2023.