Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436729
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Impact of MINST With and Without Splinting in Periodontitis Patients With Mobile Anterior Teeth
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
Official Title:
Impact of MINST With and Without Splinting on Clinical Periodontal Parameters and OHRQoL in Periodontitis Patients With Mobile Anterior Teeth A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical trial is to evaluate impact of Minimally Invasive Non-Surgical Therapy MINST with and without splinting on clinical periodontal parameters and Oral Health Related Quality of Life OHRQoL in periodontitis patients with mobile anterior teeth The main questions it aims to answer are
Does splinting provide additional benefit to MINST alone for improving the clinical periodontal parameters
Does splinting provide additional benefit to MINST alone for improving OHRQoL
Does splinting provide additional benefit to MINST alone for improving the clinical periodontal parameters
Does splinting provide additional benefit to MINST alone for improving OHRQoL
Detailed Description:
The increased mobility of a periodontally affected tooth can be caused by a shift of centre of rotation of the tooth apically due to clinical attachment loss CAL and alveolar bone loss ABL andor due to secondary occlusal trauma
Tooth splinting continues to be a topic of controversy It remains one of the most poorly understood and controversial areas of dental therapy
Minimally invasive non-surgical periodontal therapy MINST has been introduced for minimizing tissue trauma and enhancing clinical outcomes by the adjunctive use of magnification devices
This study aims to compare clinical periodontal parameters and Oral Health Related Quality of Life OHRQoL following Minimally Invasive Non-Surgical Therapy MINST both with and without splinting in patients with Stage III and Stage IV periodontitis who have mobile anterior teeth
Patients will be screened and enrolled based on specific eligibility criteria Baseline measurements of outcome parameters will be taken followed by supragingival scaling and patients will be recalled after one week
During the subsequent visit patients will be randomized into either the test group or the control group The test group will receive MINST along with splinting of the mobile anterior teeth while the control group will receive MINST alone
Patients will be recalled after 8 weeks and 6 months to assess changes in the outcome measurements
Tooth splinting continues to be a topic of controversy It remains one of the most poorly understood and controversial areas of dental therapy
Minimally invasive non-surgical periodontal therapy MINST has been introduced for minimizing tissue trauma and enhancing clinical outcomes by the adjunctive use of magnification devices
This study aims to compare clinical periodontal parameters and Oral Health Related Quality of Life OHRQoL following Minimally Invasive Non-Surgical Therapy MINST both with and without splinting in patients with Stage III and Stage IV periodontitis who have mobile anterior teeth
Patients will be screened and enrolled based on specific eligibility criteria Baseline measurements of outcome parameters will be taken followed by supragingival scaling and patients will be recalled after one week
During the subsequent visit patients will be randomized into either the test group or the control group The test group will receive MINST along with splinting of the mobile anterior teeth while the control group will receive MINST alone
Patients will be recalled after 8 weeks and 6 months to assess changes in the outcome measurements
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