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NCT Number: NCT05681754

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Procedure

Endodontic treatment with conventional sealer followed by periodontal treatment with 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

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. 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)

    Changes in levels of inflammatory markers and growth factors in blood, saliva and GCF (T1, T2, T3, T5, T7, T8, T9)

  2. 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)

    Plaque, Salivary and root canal samples for microbiome analysis

  3. 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)

    Expression of inflammatory mediators from granulation tissue derived from periodontal intrabony defects (T6)

  4. 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)

    This will be measured using standardised questionnaire, the Oral Health Impact Profile short form (OHIP-14)

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Lu

CONTACT

[email protected]

Sadia Niazi

CONTACT

[email protected]

+44 (0) 2071887459

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2033
First posted
Jan 12, 2023
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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