This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining the proprioceptive sensation of the tooth - all important advantages when treating young children.
Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.
Participants have symptoms typical of irreversible pulpitis in one of the primary molars.
The pulp of the affected primary molar is vital.
Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.
Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling).
Pre-operative periapical radiograph suggests presence of periapical radiolucency or pathologic root resorption.
Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
Signs of extensive radicular pulp inflammation i.e., root pulp bleeding continues even after 6-min.
Parallel
Pulpotomy
Procedure/SurgeryPulpotomy is a conservative pulp treatment option where only the coronal pulp is removed and a bioactive medicament (MTA) is placed over the remnant radicular pulp after haemostasis is achieved.
Pulpectomy
Procedure/SurgeryPulpectomy is treatment procedure in primary teeth where the entire coronal and radicular pulp is extirpated and the root canal system filled with a resorbable material (Vitapex/Metapex)
Post-treatment clinical outcomes based on presence/absence of pain, tenderness, or signs of infection/pathologic mobility
Clinical outcome success will be determined at 6-, 12-, and 24-months based on the treated tooth meeting all the below criteria: (i) Treated tooth is not associated with any pain or discomfort; (ii) Treated tooth is not associated with tenderness on percussion or palpation; (iii) Treated tooth is not associated with any swelling, parulis, or fistula; (iv) Treated tooth is not associated with any pathological mobility
Post-treatment radiographic outcomes based on presence/absence of pathologic root resorption, new furcal or periapical lesions, or size change of any pre-treatment furcal rarefaction
Radiographic outcome success will be determined at 6-, 12-, and 24-months based on the pulpotomy treated tooth meeting all the below criteria: - No signs of pathological internal/external root resorption or new furcal/periapical lesions on recall periapical radiographs - Complete radiographic healing or reduction/no change in size of any pre-treatment furcal rarefaction on recall periapical radiographs
Immediate post-treatment pain relief
Pain scores that will be recorded at 24-hours and 7-days post-treatment using a child friendly Visual Analogue Scale (VAS). The VAS has five-point pain score: 0-No Pain; 1-Mild Pain; 2-Moderate Pain; 3-Severe Pain; and 4-Very Severe Pain. This VAS pain score will be used to evaluate pain reduction afforded by the treatment intervention.
Click on the lead sponsor to view all of their trials.
Qatar University
Lead sponsor
Jordan University of Science and Technology
Collaborator
Primary Health Care Corporation, Qatar
Collaborator
Cairo University
Collaborator
Christian Dental College
Collaborator