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

NCT05681754 | Not Yet Recruiting

• 1 other identifier: EDGE 147667
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Endodontic Disease; Periodontitis

Keywords

Endo-perio lesions

Outcome Measures

Primary Outcomes (3)

• Probing pocket depth change in mm

  Probing pocket depth change in mm at 12months (T8); at 18months (T9)

  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)

  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)

  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)

  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)

  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)

  Surgical periodontal treatment, within 6-8 months from endodontic treatment (T6)

• Patient reported outcome measures (PROMs)

  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)

Study Arms (4)

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)

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)

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)

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

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

Interventions

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

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

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

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

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

RCT using conventional sealer and L-PRF + GTR

Experimental: RCT using hydraulic calcium silicate sealer and GTR PROCEDURE

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

RCT using hydraulic calcium silicate sealer and GTR

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

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Guy'S and St Thomas' Nhs Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Dental Pulp Diseases; Periodontitis

Interventions

Bone Substitutes

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Biocompatible Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Sadia Niazi

  King's College London, London SE1 9RT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sadia Niazi

CONTACT

+44 (0) 2071887459; sadia.niazi@kcl.ac.uk

Emily Lu

CONTACT

emily.lu@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Operators for endodontic - periodontal treatment will be different from the assessors for the initial assessments and subsequent review appointments. The Treatment will be masked for the patient and assessor. As the blood samples will be collected from the patients at T6 for biomarker analysis, therefore the patient can be masked about the treatment as these blood can be used for the LPRF treatment for those patient who are randomised in the LPRF group. The statistician will also be blinded to the allocations and will only conduct the analysis in a semi-blinded way (group 1 vs group 2 vs group 3 vs group 4) without knowing the corresponding groups until the analysis is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 12, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2033
• Last Updated: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)