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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:
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) and/or 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINST with Splinting | Experimental | Minimally Invasive Non-Surgical Therapy will be done along with splinting of mobile anterior teeth |
|
| MINST without Splinting | Active Comparator | Minimally Invasive Non-Surgical Therapy will be done without splinting of mobile anterior teeth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Splinting | Procedure | The joining of two or more teeth into a rigid unit by means of a fixed or removable restorations/devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Clinical Attachment Level (CAL) | Clinical attachment level is the distance between the cemento-enamel junction and the base of pocket. | 12 - 14 months |
| Changes in Oral Health Related Quality of Life (OHRQoL) | OHRQoL will be measured using a validated version of Oral Health Index Profile (OHIP) | 12 - 14 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Navi Bansal, BDS | PGIDS, ROHTAK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIDS | Rohtak | Haryana | 124001 | India |
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| ID | Term |
|---|---|
| D014086 | Tooth Mobility |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D013165 | Splints |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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| MINST alone | Procedure | Minimally invasive non surgical therapy alone |
|
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |