Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorAl-Azhar University

About this trial

This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Vital mandibular molar teeth with mature apices.

Teeth that respond positively to cold testing.

Teeth without any signs of necrosis including sinus tract or swelling.

Teeth with caries extending ≥ 2/3 of dentine or exposing the pulp.

Disqualifiers

Non-vital teeth.

Teeth with irreversible pulpitis with apical periodontitis.

Teeth with immature apices.

Teeth with Periodontal disease or mobility grade II or III.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calcium silicate-based sealer full Pulpotomy

    Procedure/Surgery

    Using calcium silicate-based sealer as a capping agent after full pulpotomy

  • Calcium silicate-based premixed putty full Pulpotomy

    Procedure/Surgery

    Using calcium silicate-based premixed putty as a capping agent after full pulpotomy

  • Full Pulpotomy

    Procedure/Surgery

    Using combination between calcium silicate-based sealer and calcium silicate-based premixed putty as a capping agent after full pulpotomy

Treatment groups

78 Participants
are divided into 3 treatment groups
Group A: calcium silicate-based sealerExperimental treatment 1 intervention
Group B: Premixed calcium silicate-based puttyActive comparator 1 intervention
Group C: combination between calcium silicate-based sealer and premixed calcium silicate-based puttyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical success after full pulpotomy procedure

Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.

Time frame
immediate postoperative
2

Radiographic success after full pulpotomy procedure

Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.

Time frame
immediate postoperative
3

Clinical success after full pulpotomy procedure

Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling, absence of sinus tract or fistula and absence of tooth mobility.

Time frame
At 1 month
4

Cinical success after full pulpotomy procedure

Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.

Time frame
At 3 months

Secondary outcomes

1

Assessment of Post-operative pain after full pulpotomy procedure

The postoperative pain was assessed by using the modified verbal descriptor Scale (mVDS). Patients were instructed to place a mark on the horizontal scale to represent the intensity of pain experienced, furthermore, they were asked to use the verbal descriptors as a guide. The level of pain was documented at the range of 0-10 numerically and verbally as no pain (0), slight pain (1, 2), moderate pain (3-5), strong pain (6, 7), severe pain (8), and maximum pain (9, 10).

Time frame
6 hours, 24 hours, 48 hours, 72 hours and 7 days

Other outcomes

Sponsors and contacts

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