Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03343366
Status:
COMPLETED
Last Update Posted:
2020-08-21
First Post:
2017-11-09
Brief Title:
Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy
Sponsor:
Dow University of Health Sciences
Organization:
Dow University of Health Sciences
Study Overview
Official Title:
Glycemic Control in Type-2 Diabetes Mellitus Patients Through Non-Surgical Periodontal Therapy A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is submitted that incident and prevalent chronic periodontal infection known as chronic periodontitis CP possibly has a causal relationship with diabetes mellitus DM having effects on HbA1c fasting plasma blood glucose FPG FBG and fasting plasma insulin FPI levels Experimental research has suggested that treating CP may improve glycemic control and insulin resistance in Non-Insulin Dependent Type-2 DM patients T2DM However there is limited data concerning the need and effects of adjunct antibiotic therapy AAT along with scaling root planning SRP in treating CP for long lasting results Therefore it is suggested that further research with larger samples must be undertaken for a successful periodontal therapy that may help improve glycemic control at desired levels and longer durations This study is designed to evaluate effects of periodontal therapy SRP metronidazole MET and oral hygiene instructions OHI through three-arm trial experiment comprising of SRPMETOHI SRPOHI and OHI Delayed Therapy DT groups on HbA1c FBG FPI levels and Insulin Resistance calculated through Homeostasis Model Assessment HOMA-IR to fill research gap This study will target large number of individuals N 1000 at trial camps known as diabetes-periodontitis Diab-Per camps at three different campuses of Dow University of Health Sciences hospitals to be screened for presence of signs and symptoms of chronic periodontitis and type-2 diabetes Mellitus The selected candidates will be referred to the base camp for further evaluation to be enrolled in trial and recruit 150 participants randomly allocated in each group 50 in each group Post-therapy follow-up results will be assessed at 1 3 and 6 months to evaluate short and long term changes in status of CP FBG FPI and HbA1c
Detailed Description:
The overall evidence that CP has a role in the causal pathway of DM is yet limited and inconsistent Although intervention research has suggested that treating CP may improve glycemic control and insulin resistance in Type-2 DM patients yet there is limited data concerning the effects of adjunct antibiotic therapy AAT in addition to scaling root planning SRP in treating CP for long lasting results Therefore it is suggested that further research with bigger samples must be undertaken for a successful periodontal therapy that may help improve glycemic control at desired levels and long durations
This study is designed to evaluate the effects of periodontal therapy SRP metronidazole MET and oral hygiene instructions OHI through a three-arm trial comprising of SRPMETOHI group SRPOHI group and OHI Delayed Therapy DT group on HbA1c FBG FPI levels and Insulin Resistance calculated through Homeostasis Model Assessment HOMA-IR to fill the research gap
A parallel group single blind three-arm design randomized controlled trial RCT will be conducted over a period of approximately 2 years
More than 1000 patients will be screened for CP with T2DM to recruit 150 participants for the study They will be randomly allocated in each group with 50 in each group Post-therapy follow-up will be for 1 3 and 6 months to evaluate short term and long term changes in status of CP FBG FPI and HbA1c respectively
Structured screening form will be used to collect baseline information HbA1c FBG levels and IL will be recorded at standardized lab whereas CP will be evaluated using standardized periodontal indices by calibrated examiners
Stata version 110 will be used for all kind of data management Descriptive analysis will be performed using frequency percentages of the categorical variables whereas mean standard deviation will be calculated for all continuous study variables Inferential statistics will include Chi-square test to assess proportional differences of the categorical variables between the three interventional groups Whereas one-way Analysis of Variance test ANOVA will be used to evaluate the mean differences of the continuous variables in three different groups McNemars Chi-square and Repeated Measure Analysis of Variance RMANOVA will be used to assess differences in categorical and continuous variables respectively over time for each intervention group and particularly to assess second secondary study objective For insulin resistance HOMA-IR will be calculated to assess an association between CP and insulin resistance
This study is designed to evaluate the effects of periodontal therapy SRP metronidazole MET and oral hygiene instructions OHI through a three-arm trial comprising of SRPMETOHI group SRPOHI group and OHI Delayed Therapy DT group on HbA1c FBG FPI levels and Insulin Resistance calculated through Homeostasis Model Assessment HOMA-IR to fill the research gap
A parallel group single blind three-arm design randomized controlled trial RCT will be conducted over a period of approximately 2 years
More than 1000 patients will be screened for CP with T2DM to recruit 150 participants for the study They will be randomly allocated in each group with 50 in each group Post-therapy follow-up will be for 1 3 and 6 months to evaluate short term and long term changes in status of CP FBG FPI and HbA1c respectively
Structured screening form will be used to collect baseline information HbA1c FBG levels and IL will be recorded at standardized lab whereas CP will be evaluated using standardized periodontal indices by calibrated examiners
Stata version 110 will be used for all kind of data management Descriptive analysis will be performed using frequency percentages of the categorical variables whereas mean standard deviation will be calculated for all continuous study variables Inferential statistics will include Chi-square test to assess proportional differences of the categorical variables between the three interventional groups Whereas one-way Analysis of Variance test ANOVA will be used to evaluate the mean differences of the continuous variables in three different groups McNemars Chi-square and Repeated Measure Analysis of Variance RMANOVA will be used to assess differences in categorical and continuous variables respectively over time for each intervention group and particularly to assess second secondary study objective For insulin resistance HOMA-IR will be calculated to assess an association between CP and insulin resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None