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

NCT06436729 | Active Not Recruiting DMC

• 1 other identifier: Navi Bansal Perio 24/39
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 ?

Conditions

Tooth Mobility; Periodontitis

Keywords

Splinting; OHRQoL; MINST

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

MINST with Splinting

EXPERIMENTAL

Minimally Invasive Non-Surgical Therapy will be done along with splinting of mobile anterior teeth

Procedure: Splinting

MINST without Splinting

ACTIVE COMPARATOR

Minimally Invasive Non-Surgical Therapy will be done without splinting of mobile anterior teeth

Procedure: MINST alone

Interventions

Splinting PROCEDURE

The joining of two or more teeth into a rigid unit by means of a fixed or removable restorations/devices

MINST with Splinting

MINST alone PROCEDURE

Minimally invasive non surgical therapy alone

MINST without Splinting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Tooth Mobility; Periodontitis

Interventions

Splints

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Navi Bansal, BDS

  PGIDS, ROHTAK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: June 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)