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Completed

NCT Number: NCT06436729

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

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 ?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PGIDS

Rohtak, Haryana, 124001, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Splinting

Procedure

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

MINST alone

Procedure

Minimally invasive non surgical therapy alone

Primary outcomes

  1. Changes in Clinical Attachment Level (CAL)

    Time frame: 12 - 14 months

    Clinical attachment level is the distance between the cemento-enamel junction and the base of pocket.

  2. Changes in Oral Health Related Quality of Life (OHRQoL)

    Time frame: 12 - 14 months

    OHRQoL will be measured using a validated version of Oral Health Index Profile (OHIP)

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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