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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKing's College London

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

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

    Procedure/Surgery

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

  • Experimental: RCT using hydraulic calcium silicate sealer and GTR

    Procedure/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/Surgery

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

Treatment groups

115 Participants
are divided into 4 treatment groups
Group A: RCT using hydraulic calcium silicate sealer and L-PRF + GTRExperimental treatment 1 intervention
Group B: RCT using conventional sealer and L-PRF + GTRExperimental treatment 1 intervention
Group C: RCT using hydraulic calcium silicate sealer and GTRExperimental treatment 1 intervention
Group D: RCT using conventional sealer and GTR (bone substitute + collagen membrane)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Probing pocket depth change in mm

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

Time frame
at 12months (T8); at 18months (T9)
2

Clinical attachment level (CAL) change in mm

Clinical attachment level (CAL) change in mm at 12months (T8); at 18months (T9)

Time frame
at 12months (T8); at 18months (T9)
3

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)

Time frame
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)

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)
2

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

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)
3

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)

Time frame
Surgical periodontal treatment, within 6-8 months from endodontic treatment (T6)
4

Patient reported outcome measures (PROMs)

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

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)

Other outcomes

Sponsors and contacts

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