Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT05681754

Endo-perio Disease - Treatment Outcomes Using Conventional and Hydraulic Calcium Silicate Sealer With or Without LPRF

Sponsor: King's College London

View on ClinicalTrials.gov

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 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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2023-05

Completion Date

2033-05

Last Updated

2023-01-12

Healthy Volunteers

Conditions

Endodontic Disease Periodontitis

Interventions

PROCEDURE

Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTR

Endodontic treatment with hydraulic calcium silicate sealer, followed by periodontal surgery using GTR +/- LPRF

PROCEDURE

Experimental: RCT using conventional sealer and L-PRF + GTR

Endodontic treatment with conventional sealer followed by periodontal treatment with PRF + GTR

PROCEDURE

Experimental: RCT using hydraulic calcium silicate sealer and GTR

Endodontic treatment with hydraulic calcium silicate sealer, followed by periodontal surgery using GTR only

PROCEDURE

Active Comparator: RCT using conventional sealer and GTR (bone substitute + collagen membrane)

Endodontic treatment with conventional sealer followed by periodontal treatment with GTR only

Inclusion Criteria: * • 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) Exclusion Criteria: * 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, * 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

Locations (1)

Guy'S and St Thomas' Nhs Foundation Trust

London, United Kingdom

Clinical Research Directory

Endo-perio Disease - Treatment Outcomes Using Conventional and Hydraulic Calcium Silicate Sealer With or Without LPRF

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)