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

Impact of MINST With and Without Splinting on Clinical Periodontal Parameters and OHRQoL in Periodontitis Patients With Mobile Anterior Teeth: A Randomized Controlled Trial

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 ?

Study Overview

• Status: Completed
• Conditions: Periodontitis; Tooth Mobility
• Intervention / Treatment: Procedure: Splinting; Procedure: MINST alone

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) 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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MINST with Splinting; Minimally Invasive Non-Surgical Therapy will be done along with splinting of mobile anterior teeth	Procedure: Splinting; The joining of two or more teeth into a rigid unit by means of a fixed or removable restorations/devices
Active Comparator: MINST without Splinting; Minimally Invasive Non-Surgical Therapy will be done without splinting of mobile anterior teeth	Procedure: MINST alone; Minimally invasive non surgical therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Navi Bansal, BDS, PGIDS, ROHTAK

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: MINST; Splinting; OHRQoL
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Tooth Mobility; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Splints
• Other Study ID Numbers: Navi Bansal Perio 24/39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No