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there is limited endodontic research on the effects of DM on pulp tissues. Diabetic human and animal histological research have demonstrated decreased wound repair, chronic pulp inflammation and reduced dentin bridge formation. To date, no human clinical trial has examined the impact of diabetes mellitus on teeth with irreversible pulpitis. Due to the paucity of data in the literature, there is a clinical dilemma whether to recommend root canal therapy or vital pulp therapy in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy versus root canal treatment in T2DM patients with irreversible pulpitis. The aim of this study is to compare and evaluate the success rates of pulpotomy and root canal treatment in type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In extremely deep carious lesion with symptomatic irreversible pulpitis, vital pulp therapy procedures in the form of complete pulpotomy is a more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Scientific literature indicates that type 2 diabetes mellitus has a detrimental effect on the wound healing capacity of dental pulp, however lacks evidence in clinical studies. to the best of our knowledge no study has been done till date comparing the outcome of complete pulpotomy and root canal treatment in patients with type 2 diabetes mellitus with clinical signs of irreversible pulpitis.
Aim- To compare the outcome of complete pulpotomy and root canal treatment in mandibular permanent posterior teeth with clinical signs indicative of irreversible pulpitis in patients with type 2 diabetes mellitus
Objectives-
Population - Permanent mandibular posterior teeth with diagnosis of symptomatic irreversible pulpitis in patients with Type 2 Diabetes Mellitus.
Intervention/Treatment- complete pulpotomy
Comparator- Root canal treatment
Outcome- success of complete pulpotomy versus root canal treatment based on clinical and radiographic findings at 3, 6 and 12 months secondary outcome: assessment of quality of life 1 week, 6 and 12 months post treatment.
Time frame - 1 year
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| complete pulpotomy | Experimental | complete pulpotomy will be performed in teeth with irreversible pulpitis in diabetic patients. |
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| Root Canal Treatment | Active Comparator | root canal treatment will be performed in teeth with irreversible pulpitis in diabetic patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| complete pulpotomy | Procedure | the exposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 5 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 5 minutes. After hemostasis, MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using a carrier. This will be followed by application of a layer of light-cure RMGIC and light-curing for 20 sec. The tooth then will be restored using composite resin following etch and rinse technique. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical success | Clinical success criteria No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract. | 12 months |
| radiographic success | Radiographic success criteria No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life assessment | OHRQoL assessment: OHIP-14 questionnare will be used to assess the quality of life. OHIP- 14 developed by Slade is a well-validated and reliable tool to assess OHRQoL. It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale: never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst At the follow-up visits (1 week, 6 months, and 1 year), the patients will be reporting their responses after receiving the treatment by selecting from the following 3 options: the treatment will be improving the situation, the treatment will be worsening the situation, and no change will be being noticed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jigyasa Duhan, MDS | Contact | +91 9896270449 | prashitiduhan@rediffmail.com | |
| Anmol Jain | Contact | +91 9599724799 | drjain.anmol@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jigyasa Duhan, MDS | PGIDS Rohtak | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIDS Rohtak | Recruiting | Rohtak | Haryana | 124001 | India |
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| Root canal treatment | Procedure | RCT will be performed in single visit. Root canal orifices will be explored using a DG 16 probe. A size 10 or 15 K-file will be passively inserted into the coronal two- thirds of the canal to verify a smooth glide path. Coronal enlargement will be done using Gates-Glidden drills. Working length will be determined with the help of electronic apex locator and will be confirmed radiographically. Canals will be prepared using the crown down technique with NiTi rotary instruments. The master apical file (MAF) size for each canal will be selected to be three sizes larger than the initial apical binding file at the WL. 5ml of 5.25% sodium hypochlorite using a 30-gauge side-vented needle will be used for optimal irrigation after each instrument. After completion of canal instrumentation, the canals will be irrigated with 5.0 ml of 17% ethylene-diamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% sodium hypochlorite. Canals will be dried with |
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| 12 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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