Impact of MINST With and Without Splinting in Periodontitis Patients With Mobile Anterior Teeth

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436729
• Other study ID #: Navi Bansal Perio 24/39
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Ritika Arora, MDS
• Phone: 9810734445
• Email: drritika44[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ?

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) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria at the patient level: systemically healthy patient with presence of stage III or IV periodontitis, age = 18 years.

• Tooth-related inclusion criteria: presence of at least one anterior tooth with mobility in combination with a clinical attachment loss (CAL) = 5 mm and a relative alveolar bone loss (ABL) of = 50% at the affected tooth.

• Dentition with at least 3 antagonistic contact zones opposing posterior teeth, that is Eichner Class A1, A2, A3, B1

Exclusion Criteria:

• Patients with anterior cross bite

• Bruxism or signs of parafunction

• Implant in Anterior teeth

• Any active periodontal therapy in last 1 year

• Mobility of teeth due to acute trauma

• Pulpal or periapical pathology in anterior teeth

• Patient requiring any emergency dental procedure

• Patient on antibiotic therapy in last 1 month

• If patient want to undergo surgical treatment for management of periodontitis.

Related Conditions & MeSH terms

• Periodontitis
• Tooth Mobility

Intervention

Procedure:
• Splinting
The joining of two or more teeth into a rigid unit by means of a fixed or removable restorations/devices
• MINST alone
Minimally invasive non surgical therapy alone

Locations

Country	Name	City	State
India	PGIDS	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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