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

NCT05681754 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-01-12

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Sadia Niazi · King's College London, London SE1 9RT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2027-05-31
Completion
2033-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681754 on ClinicalTrials.gov