- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03905590
Efficacy of Guided Tissue Regeneration in the Healing of Periapical Defects With Periodontal Communication Using CBCT
To Evaluate the Efficacy of Guided Tissue Regeneration in the Healing of Periapical Defects With Periodontal Communication :A Randomized Controlled Trial With 3D Analysis Using CBCT."
Study Overview
Status
Conditions
Detailed Description
Study Title: - To evaluate the efficacy of guided tissue regeneration in the healing of periapical defects with periodontal communication: A randomized controlled trial with 3D analysis using CBCT.
Rationale: - Healing of lesions with apicomarginal defects is often less satisfactory. Various studies and case reports have reported high success rate with the use of guided tissue regeneration technique. Only few clinical trials have evaluated the effect of guided tissue regeneration on the healing of apicomarginal defects. To best of our knowledge only two studies have conducted randomized controlled trial. However, no study has used CBCT for the assessment of healing in such type of lesions. So, this is the first randomized controlled trial studying the effect of guided tissue regeneration in the healing of periapical defects with periodontal communication using 3D radiological evaluation using CBCT.
Aim & Objectives: - 1. To evaluate the difference in the healing outcome of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique 2. To evaluate the difference in the healing outcome derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.
Setting: - Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics.
Study Design: - A randomized controlled trial Time Frame: - 12 to 18 months Population / Participants: - Patients of age 16 years (male/female) and above will be enrolled in the study.
Inclusion criteria: - Patients of age 16 years and above, Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's, periapical defect with periodontal communication, periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root ., -ve response to vitality test, failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.
Exclusion criteria: -Presence of buccal bone on flap elevation, Unrestorable tooth, fractured /perforated roots, smokers, pregnant females and lactating mothers.
Sample size: - 30 patients (15 patients in each group) Methods: - Diagnosis of the lesion will be made clinically and radiographically, vitality will be checked by EPT, preoperative clinical evaluation will include, clinical attachment level, gingival marginal position and pocket depth. Marginal bone loss, width of bony crypt, height of the bony crypt, depth of the crypt and height of the buccal bone plate (if present) will be measured radiographically and at the time of surgery. Surgical procedures will be carried out under operating microscope with 8 × 16 magnification by the standardized treatment methods.
Outcome measures: - Follow up of patients will be carried out at 3, 6, 9 & 12 months and outcome measures will be assessed clinically by absence of signs and symptoms and 2 dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3 dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical healing and buccal bone level.
Statistical method: - The data will be entered into Microsoft Excel and analysed using SPSS (Statistical Package for Social Science) package for relevant statistical comparison. Distribution of data into normal and non-normal will be done by Kolmogorov-Smir-Nov test. If the data will be normal then student T test and paired T test will be applied for unpaired and paired data respectively. For categorical data Chi - square test will be applied. The interobserver analysis will be done by cohen kappa analysis.
If the data will be non-normal then Mann - Whitney and Wilcoxon rank sum test will be applied for unpaired and paired data respectively. For categorical data Chi - square test will be applied. The interobserver analysis will be done by cohen kappa analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Post Graduate Institute of Dental Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Patients of age 16 years and above.
- Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's.
- periapical defect with periodontal communication.
- Periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.
- Negative response to vitality test.
- failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.
Exclusion criteria: -
- Presence of buccal bone on flap elevation.
- Unrestorable tooth.
- fractured /perforated roots.
- smokers.
pregnant females and lactating mothers
.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: periapical surgery with amniotic membrane
periapical surgery will be done and amniotic membrane will be placed over the defect before closure of flap
|
periapical surgery will be done followed by amniotic membrane placement over the defect
|
Active Comparator: periapical surgery without amniotic membrane
periapical surgery will be done without the placement of amniotic membrane over the defect before closure of flap
|
periapical surgery will be done without placement of membrane over the defect.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
healing of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique
Time Frame: BASE LINE TO 1YEAR
|
Follow up of patients will be carried out at 3, 6, 9 & 12 months and outcome measures will be assessed clinically by absence of signs and symptoms and 2 dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3 dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical healing and buccal bone level.
|
BASE LINE TO 1YEAR
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the difference in the healing outcome as observed derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.
Time Frame: BASE LINE TO 1 YEAR
|
The comparison of healing will be done 2 dimensionaly and 3 dimensionaly
|
BASE LINE TO 1 YEAR
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RITIKA YADAV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Apico Marginal Defects
-
Postgraduate Institute of Dental Sciences RohtakUnknownApico Marginal DefectsIndia
-
Narendranath EpperlaWithdrawnRecurrent Marginal Zone Lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Refractory Marginal Zone Lymphoma | Refractory Nodal Marginal Zone Lymphoma | Recurrent Nodal Marginal Zone Lymphoma | Recurrent Splenic Marginal Zone Lymphoma | Refractory Splenic Marginal Zone Lymphoma and other conditions
-
International Extranodal Lymphoma Study Group (IELSG)Active, not recruitingSplenic Marginal Zone Lymphoma | Marginal Zone Lymphoma | Nodal Marginal Zone LymphomaFrance, Switzerland, Italy, Belgium, Portugal
-
Narendranath EpperlaNot yet recruitingRecurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Refractory Mantle Cell Lymphoma | Refractory Marginal Zone Lymphoma | Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid... and other conditionsUnited States
-
Medical University of ViennaTerminatedKeratoconus | Pellucid Marginal DegenerationAustria
-
Nobel BiocareRecruitingMarginal Bone Level ChangeDenmark
-
The University of Hong KongUnknownDental Restoration Failure of Marginal IntegrityChina
-
Moorfields Eye Hospital NHS Foundation TrustSooft Italia; Accuvision Laser Eye Clinics; Carleton Optical Equipment Ltd.; Bon...CompletedKeratoconus | Pellucid Marginal DegenerationUnited Kingdom
-
National Cancer Institute (NCI)CompletedRecurrent Adult Acute Myeloid Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone Lymphoma | Recurrent Adult Acute Lymphoblastic Leukemia | Recurrent Small Lymphocytic... and other conditionsUnited States
-
International Extranodal Lymphoma Study Group (IELSG)CompletedMarginal Zone B-cell LymphomaItaly, France
Clinical Trials on Periapical surgery with amniotic membrane
-
Postgraduate Institute of Dental Sciences RohtakUnknownApicomarginal DefectsIndia
-
Postgraduate Institute of Dental Sciences RohtakRecruitingApicomarginal DefectsIndia
-
Postgraduate Institute of Dental Sciences RohtakUnknownPeriapical LesionIndia
-
Postgraduate Institute of Dental Sciences RohtakCompleted
-
Postgraduate Institute of Dental Sciences RohtakUnknownPeriapical Lesions
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
University of AlexandriaCompleted
-
OrthoCarolina Research Institute, Inc.Completed
-
Postgraduate Institute of Dental Sciences RohtakUnknownPeriapical Lesions
-
Instituto Universitario de Oftalmobiología Aplicada...University of Valladolid; Red de Terapia Celular; Centro en Red de Medicina Regenerativa...CompletedLimbus Corneae Insufficiency SyndromeSpain