Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-30
SponsorKing Abdullah University Hospital
About this trial
This study will evaluate whether full pulpotomy can successfully treat mature permanent teeth with irreversible pulp inflammation and a periapical lesion. Full pulpotomy involves removing the inflamed pulp tissue from the crown of the tooth while preserving the healthy tissue inside the roots. The study will assess pain relief, patient satisfaction, and clinical and radiographic healing over time, including healing of the periapical lesion using dental X-rays and limited-field CBCT imaging. The findings may help determine whether full pulpotomy can provide a less invasive alternative to root canal treatment for selected teeth with periapical lesions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• Non -contributory medical history (SAI, II).
Posterior permanent tooth (premolar, molar).
Age range 8-30 years
Deep caries extending into the inner quarter of dentin or exposing the pulp on the periapical radiograph
Disqualifiers
Non-restorable tooth.
Signs of pulpal necrosis including sinus tract or swelling.
Evidence of necrotic tissue in one or all canals.
Profuse pulpal bleeding and inability to achieve hemostasis.
Trial design
Design model
Single group
Treatments tested in this trial
Full pulpotomy
Procedure/SurgeryFull pulpotomy will be performed in permanent teeth with irreversible pulpitis and apical periodontitis, with diode laser-assisted hemostasis and calcium silicate-based pulp capping. The intervention is distinguished by the treatment of teeth with radiographic evidence of apical periodontitis using a full pulpotomy approach rather than conventional root canal treatment.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Success of pulpotomy
Treatment success will be determined by the absence of clinical signs and symptoms of disease, together with radiographic evidence of healing or reduction of the periapical lesion.
Time frame
6 and 12 monthsSecondary outcomes
1
Postoperative pain
Postoperative pain will be assessed using a numerical rating scale from 0 to 10, where 0 represents no pain and 10 represents the most severe pain.
Time frame
3 and 7 days after treatmentOther outcomes
1
Oral health-related quality of life
Oral health-related quality of life will be assessed using the Oral Health Impact Profile questionnaire modified for endodontic treatment.
Time frame
Before treatment, 1 week and 12 months after treatment2
Tooth Survival
Tooth survival will be assessed based on percentage of the treated teeth remains present and functional during the follow-up period.
Time frame
12, 24, and 36 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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