Glycemic Levels on Healing of Periapical Lesions in Type 2 Diabetic Patients
Condition: Periapical Lesions
Study type: Interventional

Summary: 
      Increased incidence of peri-radicular lesions have been reported in diabetic patients which
      has been implicated due to compromised immune response. Much research has been done on the
      pathogenesis and progression of this lesion in diabetic patients. Although there are few
      studies which focus on healing of periradicular lesions after nonsurgical root canal
      treatment. There is a lacunae in literature which highlights peri-radicular healing after
      nonsurgical root canal treatment in relation to Glycaemic control in diabetic patients
      measured in terms of HbA1c levels.
    

Detailed description: 
      Diabetes mellitus is defined as a group of metabolic disorders characterized by chronic
      hyperglycemia with disturbances in carbohydrates, fat, and protein metabolism resulting from
      defects in insulin secretion, insulin action, or both. The effects of diabetes mellitus
      include long-term damage, dysfunction and failure of various organs: eyes, kidneys, nerves,
      heart, and blood vessels . Diabetes Mellitus is broadly classified into two types. Diabetes
      due to reduced insulin secretion from islet cells of pancreas is are known as type 1 and
      Diabetes due to combination of insulin resistance , reduced or increased insulin secretion
      are known as type 2.

      One of the main detrimental effects of diabetes is its downregulation of immune system. It
      affects the immune cell function, up-regulates cytokines from monocytes or leukocytes and
      down-regulates the various growth factors predisposing to chronic inflammation, progressive
      tissue breakdown and reduced tissue repair capacity . So body becomes increasingly
      susceptible to infections and worsens if the blood glucose levels are not brought back to
      normal range .Oral symptoms of uncontrolled diabetes may comprise a plethora of conditions,
      such as dry mouth, tooth decay, periodontal diseases, delayed wound healing, and increased
      incidence of infection following surgery.

      Diabetes mellitus inhibits collagen fibril formation and also interferes with collagen
      cross-linking and may impair degradation of matrix proteins and subsequent tissue remodeling
      , leading to poor wound healing in diabetics. Poor wound healing is similar in diabetic
      dental pulp.

      Apical periodontitis is a chronic inflammatory lesion of the periapical region caused due to
      release of infectious products from the infected root canal system in the case of necrotic
      non vital pulp. It is characterized by periapical bone loss which does not heal unless the
      irritating agent is removed.

      Thus, pro-inflammatory status and impaired immune response associated with systemic diseases
      can affect the reparative response of the dental pulp and periapical healing.Periapical
      immune response localizes the infection within the confines of the root canal system and
      prevents its systemic dissemination. In the host immune system, neutrophil is the first
      defense line when pathogens invade. Diabetes mellitus seriously impairs the function and
      bactericidal activity of neutrophils.

      Apical periodontitis and chronic periodontitis share many common features including common
      microbiota and chronic nature of the disease. Several studies have been conducted linking
      periodontal disease and diabetes mellitus in terms of prevalence and worsening of glycaemic
      control in diabetic's patients.

      Many studies have been done focusing on the effect of periodontal therapy on glycemic control
      in diabetes, including reviews and meta-analysis Although there are few studies which focus
      on healing of periradicular lesions after nonsurgical root canal treatment. Further research
      is necessary in this area to solidify our understanding on periapical healing and glycaemic
      control.

      Aims and objectives To evaluate the clinical and radiographic success of primary non-surgical
      root canal treatment in teeth with apical periodontitis in good controlled/poor controlled
      diabetics To evaluate the clinical and radiographic success of primary non-surgical root
      canal treatment in teeth with apical periodontitis in diabetic patients (well controlled and
      poor controlled diabetics)/non-diabetics.

      To evaluate the HbA1c levels as a means of glycemic control during the treatment of apical
      periodontitis in well controlled/poor controlled diabetic patients.

      MATERIALS AND METHODS This study will be conducted in the department of conservative
      dentistry and endodontics, post graduate institute of dental sciences, Rohtak. Study subjects
      will be obtained from the pool of OPD patients in the Department of conservative dentistry
      and endodontics, PGIDS, Rohtak. Protocol for the study will be submitted for approval to
      institutional ethical committee of PGIDS Rohtak.

      METHODOLOGY Prior to treatment a thorough clinical and radiological examination will be
      carried out.

      A thorough history will be taken from each patient. Prior informed consent will be taken
      after explaining the procedure, risks and benefits.

      Clinical procedure:

      A total of 75 patients (n=25 in each group) will be included in the study

      Sample size determination:

      Sample size was determined using Karlsson's method with a power of 0.90 , P < 0,05% and
      standard deviation ± 0.50 according to which a sample of minimum 21 patients in each group
      was calculated , but keeping in mind the attrition a total of 25 patients will be recruited
      in each group .

      First Appointment

      Mature mandibular permanent molar with diagnosis of apical periodontitis (as confirmed
      clinically & by periapical radiograph) will be chosen for the study.

      All periapical radiographs will be exposed by using constant kVP, mA and exposure time (70
      KVP, 8 mA, 0.8 sec.) with a Rinn paralleling device and processed manually.

      A customized zig will be prepared using addition silicone for each patient to keep as a
      future reference for film placement.

      Fasting and post prandial blood glucose test & glycosylated hemoglobin (HbA1c) test will be
      done to evaluate the diabetic status of the patient.

      Patients will be divide into three groups Good control diabetic patients- HbA1c levels
      ranging from 6.5%-7.5% Poor control diabetic patients-HbA1c levels greater than 7.5% Non
      diabetic Healthy controls-HbA1c levels less than 6.5% After administration of local
      anesthesia, rubber dam isolation of involved tooth will be done.

      Acess cavity will be prepared using carbide burs in high speed hand piece with copious
      irrigation.

      Negotiation of canals will be done. Working length will be determined using root ZX apex
      locator and will be verified radiographically.

      Coronal enlargement will be done using Gates-Glidden drills. Hand files No. 10, 15 and 20
      were used till working length (WL) to prepare a smooth reproducible glide path.

      Canals will be prepared using the crown down technique with protaper rotary instruments in
      which coronal enlargement will be be done by Sx,S1 and S2. Finishing until the apex will be
      done by F1 and F2.

      5ml of 5.25% sodium hypochlorite 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 1minute followed by a final irrigation with 5.0 ml of
      5.25% sodium hypochlorite Canals will be dried with absorbent paper points and filled with a
      paste of calcium hydroxide; the access cavity will be restored with intermediate restorative
      material.

      The Patients will be recalled after 1 week. Second Appointment At the next appointment, the
      paste will be removed with H-files, copious irrigant with 5.25% NaOCl will be done; and
      canals will be dried with paper points.

      Canals will be obturated with the Gutta-Percha and zinc Oxide-Eugenol based sealer.

      After obturation, the cavity will be restored permanently. Immediate post-operative
      radiograph will be taken using preset exposure parameters and will be processed manually
      Follow up clinical and radiographic examination will be carried out at 3 months, 6 months, 9
      months and 12th month.
    

Intervention name(s): Nonsurgical root canal therapy
Intervention type(s): Procedure
Intervention description(s): After administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.
Other intervention name(s): Root canal treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment