## Protocol Section
### Identification Module
**NCT ID:** NCT06426524

**Brief Title:** Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study

**Official Title:** Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study

#### Organization Study ID Info
**ID:** SVSInstituteDS1
#### Organization
**Class:** OTHER
**Full Name:** SVS Institute of Dental Sciences
### Status Module
#### Completion Date
**Date:** 2024-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-19

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dr R Viswa Chandra

#### Responsible Party

**Investigator Affiliation:** SVS Institute of Dental Sciences

**Investigator Full Name:** Dr R Viswa Chandra

**Investigator Title:** PROFFESSOR AND HEAD OF THE DEPARTMENT

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects.

**Detailed Description:** In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed.

In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed.

### Conditions Module

**Conditions:**

- Intrabony Periodontal Defect

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed.

**Intervention Names:**

- Procedure: IGF-1 Gel

**Label:** Test group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed.

**Intervention Names:**

- Procedure: Hydroxyapatite

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Test group

**Description:** After degranulation of the defect, IGF-1 gel mixed with Hydroxyapatite graft will be placed in the defect.

**Name:** IGF-1 Gel

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** After degranulation of the defect, Hydroxyapatite graft will be placed in the defect.

**Name:** Hydroxyapatite

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.

**Measure:** Bone Regeneration

**Time Frame:** 3 months and 6 months

**Description:** Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.

**Measure:** clinical attachment level

**Time Frame:** 3 months and 6 months

**Description:** Assessment of probing depth using UNC-15 probe at baseline and postoperatively at 3 and 6 months.

**Measure:** Probig depth

**Time Frame:** 3 months and 6 months

#### Secondary Outcomes

**Description:** Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.

**Measure:** Plaque Index

**Time Frame:** 3 months and 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Systemically healthy male and female patients of age \>18 years Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of \>5mm.

Exclusion Criteria:

Medically compromised patients Pregnant women Heavy smokers Patients who underwent radiotherapy or chemotherapy are excluded

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** viswachandra@hotmail.com

**Name:** Dr R Viswa Chandra, MDS;DNB;PhD

**Phone:** 8179367147

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hyderabad

**Contacts:**

***Contact 1:***

- **Email:** viswachandra@hotmail.com

- **Name:** Rampalli Viswa Chandra, MDS; DNB

- **Phone:** 9908183071

- **Role:** CONTACT

**Country:** India

**Facility:** SVS Institute of Dental Sciences, Mahabubnagar

**State:** Telangana

**Status:** RECRUITING

**Zip:** 509002

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M11900

- Name: Mitogens

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
