## Protocol Section
### Identification Module
**NCT ID:** NCT06436729

**Brief Title:** Impact of MINST With and Without Splinting in Periodontitis Patients With Mobile Anterior Teeth

**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

#### Organization Study ID Info
**ID:** Navi Bansal Perio 24/39
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Postgraduate Institute of Dental Sciences Rohtak

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 ?

**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.

### Conditions Module

**Conditions:**

- Tooth Mobility

- Periodontitis

**Keywords:**

- Splinting

- OHRQoL

- MINST

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Splinting

**Label:** MINST with Splinting

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Procedure: MINST alone

**Label:** MINST without Splinting

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MINST with Splinting

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

**Name:** Splinting

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- MINST without Splinting

**Description:** Minimally invasive non surgical therapy alone

**Name:** MINST alone

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Changes in Clinical Attachment Level (CAL)

**Time Frame:** 12 - 14 months

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

**Measure:** Changes in Oral Health Related Quality of Life (OHRQoL)

**Time Frame:** 12 - 14 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drritika44@gmail.com

**Name:** Ritika Arora, MDS

**Phone:** 9810734445

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rohtak

**Contacts:**

***Contact 1:***

- **Email:** principalpgids@yahoo.in

- **Name:** Sanjay Tewari, MDS

- **Phone:** 01262283876

- **Role:** CONTACT

**Country:** India

**Facility:** PGIDS

**State:** Haryana

**Zip:** 124001

#### Overall Officials

**Official 1:**

**Affiliation:** PGIDS, ROHTAK

**Name:** Navi Bansal, BDS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M16841

- Name: Tooth Mobility

- Relevance: HIGH

- As Found: Tooth Mobility

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000014086

- Term: Tooth Mobility

### Misc Info Module

- Version Holder: 2024-05-31
