Endodontic DiseaseNCT05681754
Endo-perio Disease - Treatment Outcomes Using Conventional and Hydraulic Calcium Silicate Sealer With or Without LPRF
A study testing Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTR, Experimental: RCT using conventional sealer and L-PRF + GTR and Experimental: RCT using hydraulic calcium silicate sealer and GTR in people with Endodontic Disease and Periodontitis, run by King's College London at 1 site in United Kingdom.
Trial summary
The endodontic periodontal-disease is characterized by the involvement of the pulp and periodontal disease in the same tooth. The anatomic connections between the dental pulp and the periodontium provide a pathway for perio-endo communication via apical foramina, lateral canals, exposed dentinal tubules, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endodontic Disease, Periodontitis
- What is being tested?
- Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTR, Experimental: RCT using conventional sealer and L-PRF + GTR and Experimental: RCT using hydraulic calcium silicate sealer and GTR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2023to May 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Diagnosis of Endodontic-periodontal disease without root damage in periodontitis patients, Grades I, II, III according to Herrera 2017 classification.
- Presence of ≥ 1 intrabony defect: interproximal probing pocket depth ≥ 5 mm and ≥ 3mm radiographic intrabony defect, adjacent to single rooted and multi-rooted teeth associated with endodontic-periodontal disease
- Age: 18-80
- Non-smokers (zero cigarettes within last 5 years)
Who cannot join
- Endodontic considerations: severely sclerosed canals, external cervical resorption and internal root resorption, perforations, root fracture or cracking, re- RCT, apical surgery and unrestorable teeth
- Teeth with defects not amenable to regeneration or molar teeth planned for root resection
- Periodontal treatment carried out previously to the study site within the last 12 months (excluding not-extensive subgingival debridement as judged by the examining clinician),
- presence of drug induced gingival overgrowth.
- Smoking (current or in past 5 years) including e-cigarettes/ vaping
- History of alcohol or drug abuse,
Show all 16Show fewer
- Systemic antibiotic therapy during the 3 months preceding the baseline exam,
- History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures,
- Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam,
- Medical history of diabetes or transmittable diseases,
- Chronic inflammatory conditions: chronic peptic ulcer, tuberculosis, rheumatoid arthritis, ulcerative colitis, crohn's disease, active hepatitis, inflammatory bowel diseases, irritable bowel syndrome, autoimmune diseases, liver diseases, renal diseases or cancer
- Medications which alter bone metabolism: hormone replacement therapy, immunosuppressive drugs, corticosteroids, selective serotonin reuptake inhibitors, tumour necrosis factor blockers, IV bisphosphonates, and/or antiresorptive drugs,
- Self-reported pregnancy or lactation
- Surgical procedures in the last 6months (any type of surgical procedures)
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation,
- Poor compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Lu contact
United Kingdom1 site
Guy'S and St Thomas' Nhs Foundation Trust
London
Emily Lu, emily.lu@kcl.ac.uk
Sadia Niazi, sadia.niazi@kcl.ac.uk
About this study
Official title: Endodontic-periodontal Disease - Comparison of Treatment Outcome Using Conventional and Hydraulic Calcium Silicate Sealer With or Without LPRF and Characterisation of Host-microbiome Interaction
The endodontic periodontal-disease is characterized by the involvement of the pulp and periodontal disease in the same tooth. The anatomic connections between the dental pulp and the periodontium provide a pathway for perio-endo communication via apical foramina, lateral canals, exposed dentinal tubules, and developmental grooves. These pathways provide an egress for pulpal disease to affect the periodontium and conversely, an ingress for periodontal disease to affect the pulp.
Teeth with endo-perio disease, which are deemed salvageable might require root canal (endodontic) treatment, followed by staged periodontal treatment. Compared to conventional sealers used for endodontic treatment, the hydraulic calcium silicate based sealers (HCSB)s have excellent sealing ability, biocompatibility, regeneration ability, and antimicrobial characteristics. However little is known about its clinical benefits when used to treat endo-perio disease.
The gold standard treatment for periodontitis affected teeth associated with intrabony lesions is guided tissue regeneration (GTR) which has significant improved clinical outcomes over open flap debridement (Cochrane systematic review 2005). However, the success the of this regenerative technique requires careful case and defect selection. We propose the use of an autologous bioactive scaffold, leukocyte platelet rich fibrin (L-PRF) to achieve regeneration of periodontal soft and hard tissues, resulting in faster healing, greater bone infill and improved predictability of clinical outcomes
Read the detailed description
Primary periodontal /secondary endodontic lesions and true combined lesions is challenging since the outcome of these is significantly less predictable than that of those arising due to primary endo disease and require multidisciplinary management involving endodontic treatment in the form of root canal treatment followed by staged periodontal treatment.
This includes initial non-surgical periodontal therapy to reduce the microbiologic burden in the periodontal pocket. After a 3-to-6 month period following the completion of endodontic treatment, the apical healing is evaluated and the periodontal condition reassessed and then the decision is made for periodontal regenerative therapies to promote the formation of new cementum, periodontal ligament, and bone to achieve esthetic and hygienic goals. These regenerative therapies include tissue engineering techniques, such as guided tissue regeneration (GTR); implantation of enamel protein matrix derivatives; application of signalling molecules, such as growth factors, and leucocyte- platelet rich fibrin (L-PRF). Without concomitant regenerative procedures, success ranges from 27% to 37%. When regenerative procedures are added to endodontic therapy, the chance of a successful outcome improves to 77.5%.
L-PRF is obtained through the centrifugation of blood resulting in a strong fibrin matrix enriched with platelets and growth factors. Previous evidence suggest that this can be successfully used in the treatment of intrabony defects, but no randomised controlled trial has been conducted examining the additional benefits of L-PRF when used in conjunction with GTR in the treatment of intrabony defects associated with endodontic-periodontal disease.
The investigators have previously also investigated the microbiome of endodontic infections using targeted 16SrRNA gene and house-keeping gene sequence analysis, we determined the predominant cultivable microbiota of primary and secondary (failed) Endodontic infections. The investigators have lately investigated the microbiome of root canal infections using next generation sequencing targeting region V1-V2 of 16SrRNA gene (unpublished data). The investigators are also currently investigating the host microbiome interactions in these conditions. Although Endodontic periodontal disease differ in pathogenicity but they do share common microbial factors and inflammatory mediators.
- Conditions
- Endodontic Disease, Periodontitis
- Being tested
- Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTR, Experimental: RCT using conventional sealer and L-PRF + GTR, Experimental: RCT using hydraulic calcium silicate sealer and GTR, Active Comparator: RCT using conventional sealer and GTR (bone substitute + collagen membrane)
- Keywords
- Endo-perio lesions
- Medical subject headings
- Dental Pulp Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTRProcedure or surgery
Endodontic treatment with hydraulic calcium silicate sealer, followed by periodontal surgery using GTR +/- LPRF
Experimental: RCT using conventional sealer and L-PRF + GTRProcedure or surgery
Endodontic treatment with conventional sealer followed by periodontal treatment with PRF + GTR
Experimental: RCT using hydraulic calcium silicate sealer and GTRProcedure or surgery
Endodontic treatment with hydraulic calcium silicate sealer, followed by periodontal surgery using GTR only
Active Comparator: RCT using conventional sealer and GTR (bone substitute + collagen membrane)Procedure or surgery
Endodontic treatment with conventional sealer followed by periodontal treatment with GTR only
| Study group | Role | What they receive |
|---|---|---|
| RCT using hydraulic calcium silicate sealer and L-PRF + GTR | Experimental | Endodontic-periodontal disease patients undergoing root canal treatment using hydraulic calcium silicate sealer and L-PRF + GTR (bone substitute + collagen membrane) Receives: Procedure: Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTR |
| RCT using conventional sealer and L-PRF + GTR | Experimental | Endodontic-periodontal disease patients undergoing root canal treatment using conventional sealer and L-PRF + GTR (bone substitute + collagen membrane) Receives: Procedure: Experimental: RCT using conventional sealer and L-PRF + GTR |
| RCT using hydraulic calcium silicate sealer and GTR | Experimental | Endodontic-periodontal disease patients undergoing root canal treatment using hydraulic calcium silicate sealer and GTR (bone substitute + collagen membrane) Receives: Procedure: Experimental: RCT using hydraulic calcium silicate sealer and GTR |
| RCT using conventional sealer and GTR (bone substitute + collagen membrane) | Active comparator | Endodontic-periodontal disease patients undergoing root canal treatment using conventional sealer and GTR (bone substitute + collagen membrane)
This is our control group Both the endodontic and periodontal lesions are managed using gold standard of care biomaterials and techniques Receives: Procedure: Active Comparator: RCT using conventional sealer and GTR (bone substitute + collagen membrane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth change in mm
Probing pocket depth change in mm at 12months (T8); at 18months (T9)
Measured: at 12months (T8); at 18months (T9)
Clinical attachment level (CAL) change in mm
Clinical attachment level (CAL) change in mm at 12months (T8); at 18months (T9)
Measured: at 12months (T8); at 18months (T9)
Change in the size of the lesion/ intrabony defect using Cone Beam CT and PA radiographs.
Change in the size of the lesion/ intrabony defect using Cone Beam CT and PA at 12months (T8); at 18months (T9)
Measured: at 12months (T8); at 18months (T9)
Secondary outcomes (4)
Changes in levels of inflammatory markers and growth factors in blood, saliva and GCF (T1, T2, T3, T5, T7, T8, T9)
Changes in levels of inflammatory markers and growth factors in blood, saliva and GCF (T1, T2, T3, T5, T7, T8, T9)
Measured: baseline (T1), Endodontic treatment, within 4 weeks from baseline (T2), Review at 3months (T3), Review at 6 months (T5), Review at 9 months (T7), Review at 12months( T8), Review at 18months (T9)
Plaque, Salivary and root canal microbiome associated with presence and healing of intrabony defects (T1, T2, T3, T5, T7, T8, T9)
Plaque, Salivary and root canal samples for microbiome analysis
Measured: baseline (T1), Endodontic treatment, within 4 weeks from baseline (T2), Review at 3months (T3), Review at 6 months (T5), Review at 9 months (T7), Review at 12months( T8), Review at 18months (T9)
Expression of inflammatory mediators from granulation tissue derived from periodontal intrabony defects (T6)
Expression of inflammatory mediators from granulation tissue derived from periodontal intrabony defects (T6)
Measured: Surgical periodontal treatment, within 6-8 months from endodontic treatment (T6)
Patient reported outcome measures (PROMs)
This will be measured using standardised questionnaire, the Oral Health Impact Profile short form (OHIP-14)
Measured: baseline (T1), Endodonic treatment, within 4 weeks from baseline (T2), Review at 3months (T3), Review at 6 months (T5), Review at 9 months (T7), Review at 12months( T8), Review at 18months (T9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sadia Niazi, Principal investigator, King's College London, London SE1 9RT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681754
- Sponsor's protocol ID
- EDGE 147667
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research data will only be accessed by PIs, or CIs involved in the research project. The PhD student and statistician will only have access to anonymised data
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodontic-periodontal Disease - Comparison of Treatment Outcome Using Conventional and Hydraulic Calcium Silicate Sealer With or Without LPRF and Characterisation of Host-microbiome Interaction
- ClinicalTrials.gov ID
- NCT05681754
- Acronym / sponsor ID
- EDGE 147667
- Conditions
- Endodontic Disease, Periodontitis
- Keywords
- Endo-perio lesions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 12 Jan 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.
The endodontic periodontal-disease is characterized by the involvement of the pulp and periodontal disease in the same tooth. The anatomic connections between the dental pulp and the periodontium provide a pathway for perio-endo communication via apical foramina, lateral canals, exposed dentinal tubules, and developmental grooves. These pathways provide an egress for pulpal disease to affect the periodontium and conversely, an ingress for periodontal disease to affect the pulp.
Teeth with endo-perio disease, which are deemed salvageable might require root canal (endodontic) treatment, followed by staged periodontal treatment. Compared to conventional sealers used for endodontic treatment, the hydraulic calcium silicate based sealers (HCSB)s have excellent sealing ability, biocompatibility, regeneration ability, and antimicrobial characteristics. However little is known about its clinical benefits when used to treat endo-perio disease.
The gold standard treatment for periodontitis affected teeth associated with intrabony lesions is guided tissue regeneration (GTR) which has significant improved clinical outcomes over open flap debridement (Cochrane systematic review 2005). However, the success the of this regenerative technique requires careful case and defect selection. We propose the use of an autologous bioactive scaffold, leukocyte platelet rich fibrin (L-PRF) to achieve regeneration of periodontal soft and hard tissues, resulting in faster healing, greater bone infill and improved predictability of clinical outcomes
Detailed description
Primary periodontal /secondary endodontic lesions and true combined lesions is challenging since the outcome of these is significantly less predictable than that of those arising due to primary endo disease and require multidisciplinary management involving endodontic treatment in the form of root canal treatment followed by staged periodontal treatment.
This includes initial non-surgical periodontal therapy to reduce the microbiologic burden in the periodontal pocket. After a 3-to-6 month period following the completion of endodontic treatment, the apical healing is evaluated and the periodontal condition reassessed and then the decision is made for periodontal regenerative therapies to promote the formation of new cementum, periodontal ligament, and bone to achieve esthetic and hygienic goals. These regenerative therapies include tissue engineering techniques, such as guided tissue regeneration (GTR); implantation of enamel protein matrix derivatives; application of signalling molecules, such as growth factors, and leucocyte- platelet rich fibrin (L-PRF). Without concomitant regenerative procedures, success ranges from 27% to 37%. When regenerative procedures are added to endodontic therapy, the chance of a successful outcome improves to 77.5%.
L-PRF is obtained through the centrifugation of blood resulting in a strong fibrin matrix enriched with platelets and growth factors. Previous evidence suggest that this can be successfully used in the treatment of intrabony defects, but no randomised controlled trial has been conducted examining the additional benefits of L-PRF when used in conjunction with GTR in the treatment of intrabony defects associated with endodontic-periodontal disease.
The investigators have previously also investigated the microbiome of endodontic infections using targeted 16SrRNA gene and house-keeping gene sequence analysis, we determined the predominant cultivable microbiota of primary and secondary (failed) Endodontic infections. The investigators have lately investigated the microbiome of root canal infections using next generation sequencing targeting region V1-V2 of 16SrRNA gene (unpublished data). The investigators are also currently investigating the host microbiome interactions in these conditions. Although Endodontic periodontal disease differ in pathogenicity but they do share common microbial factors and inflammatory mediators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RCT using hydraulic calcium silicate sealer and L-PRF + GTR | Experimental | Procedure: Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTREndodontic-periodontal disease patients undergoing root canal treatment using hydraulic calcium silicate sealer and L-PRF + GTR (bone substitute + collagen membrane) |
| RCT using conventional sealer and L-PRF + GTR | Experimental | Procedure: Experimental: RCT using conventional sealer and L-PRF + GTREndodontic-periodontal disease patients undergoing root canal treatment using conventional sealer and L-PRF + GTR (bone substitute + collagen membrane) |
| RCT using hydraulic calcium silicate sealer and GTR | Experimental | Procedure: Experimental: RCT using hydraulic calcium silicate sealer and GTREndodontic-periodontal disease patients undergoing root canal treatment using hydraulic calcium silicate sealer and GTR (bone substitute + collagen membrane) |
| RCT using conventional sealer and GTR (bone substitute + collagen membrane) | Active comparator | Procedure: Active Comparator: RCT using conventional sealer and GTR (bone substitute + collagen membrane)Endodontic-periodontal disease patients undergoing root canal treatment using conventional sealer and GTR (bone substitute + collagen membrane) This is our control group Both the endodontic and periodontal lesions are managed using gold standard of care biomaterials and techniques |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Diagnosis of Endodontic-periodontal disease without root damage in periodontitis patients, Grades I, II, III according to Herrera 2017 classification.
Key exclusion criteria (16 listed)
- Endodontic considerations: severely sclerosed canals, external cervical resorption and internal root resorption, perforations, root fracture or cracking, re- RCT, apical surgery and unrestorable teeth
- Teeth with defects not amenable to regeneration or molar teeth planned for root resection
- presence of drug induced gingival overgrowth.
- Smoking (current or in past 5 years) including e-cigarettes/ vaping
- History of alcohol or drug abuse,
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 |
|---|---|---|
| Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTREndodontic treatment with hydraulic calcium silicate sealer, followed by periodontal surgery using GTR +/- LPRF | Procedure or surgery | RCT using hydraulic calcium silicate sealer and L-PRF + GTR |
| Experimental: RCT using conventional sealer and L-PRF + GTREndodontic treatment with conventional sealer followed by periodontal treatment with PRF + GTR | Procedure or surgery | RCT using conventional sealer and L-PRF + GTR |
| Experimental: RCT using hydraulic calcium silicate sealer and GTREndodontic treatment with hydraulic calcium silicate sealer, followed by periodontal surgery using GTR only | Procedure or surgery | RCT using hydraulic calcium silicate sealer and GTR |
| Active Comparator: RCT using conventional sealer and GTR (bone substitute + collagen membrane)Endodontic treatment with conventional sealer followed by periodontal treatment with GTR only | Procedure or surgery | RCT using conventional sealer and GTR (bone substitute + collagen membrane) |
Primary outcome
Probing pocket depth change in mm
Time frame: at 12months (T8); at 18months (T9)
Probing pocket depth change in mm at 12months (T8); at 18months (T9)
Clinical attachment level (CAL) change in mm
Time frame: at 12months (T8); at 18months (T9)
Clinical attachment level (CAL) change in mm at 12months (T8); at 18months (T9)
Change in the size of the lesion/ intrabony defect using Cone Beam CT and PA radiographs.
Time frame: at 12months (T8); at 18months (T9)
Change in the size of the lesion/ intrabony defect using Cone Beam CT and PA at 12months (T8); at 18months (T9)
4 secondary outcomes
Changes in levels of inflammatory markers and growth factors in blood, saliva and GCF (T1, T2, T3, T5, T7, T8, T9)
Time frame: baseline (T1), Endodontic treatment, within 4 weeks from baseline (T2), Review at 3months (T3), Review at 6 months (T5), Review at 9 months (T7), Review at 12months( T8), Review at 18months (T9)
Plaque, Salivary and root canal microbiome associated with presence and healing of intrabony defects (T1, T2, T3, T5, T7, T8, T9)
Time frame: baseline (T1), Endodontic treatment, within 4 weeks from baseline (T2), Review at 3months (T3), Review at 6 months (T5), Review at 9 months (T7), Review at 12months( T8), Review at 18months (T9)
Expression of inflammatory mediators from granulation tissue derived from periodontal intrabony defects (T6)
Time frame: Surgical periodontal treatment, within 6-8 months from endodontic treatment (T6)
Patient reported outcome measures (PROMs)
Time frame: baseline (T1), Endodonic treatment, within 4 weeks from baseline (T2), Review at 3months (T3), Review at 6 months (T5), Review at 9 months (T7), Review at 12months( T8), Review at 18months (T9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No. The research data will only be accessed by PIs, or CIs involved in the research project. The PhD student and statistician will only have access to anonymised data
Related trials for Endodontic Disease
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
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.
Emily Lu contact
Sadia Niazi principal investigator
King's College London, London SE1 9RT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTR, Experimental: RCT using conventional sealer and L-PRF + GTR and Experimental: RCT using hydraulic calcium silicate sealer and GTR in people with Endodontic Disease and Periodontitis, run by King's College London at 1 site in United Kingdom.
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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 12 Jan 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadia Niazi (+44 (0) 2071887459, sadia.niazi@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth change in mm (time frame: at 12months (T8); at 18months (T9)). 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?
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 12 Jan 2023.