## Protocol Section
### Identification Module
**NCT ID:** NCT06433375

**Brief Title:** Evaluation of the Efficacy of Growth Hormone on Healing of Periapical Pathosis

**Official Title:** Evaluation of the Efficacy of Growth Hormone and Non-Surgical Debulking of Periapical Tissues on Healing of Periapical Pathosis

#### Organization Study ID Info
**ID:** 27/4/2023
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2025-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Al-Azhar University

#### Responsible Party

**Investigator Affiliation:** Al-Azhar University

**Investigator Full Name:** Mohamed Zakaria Abd El Aziz

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study aimed to evaluate the effect of growth hormone and non-surgical debulking of periapical tissues on healing of periapical pathosis

**Detailed Description:** Out of ninety patients, forty-eight healthy male patients aged 18 to 40 years old were selected from outpatients attending the Endodontic Clinic of the Faculty of Dental Medicine, Al-Azhar University Boys, Cairo, Egypt, to be included in this study. The selected patients have no medical contraindications for oral surgical procedures (Scores1-2) according to the classification of the American Society of Anesthesiologists (ASA)(8). Maxillary permanent incisor teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients.

### Conditions Module

**Conditions:**

- Periapical Diseases

- Growth Hormone

- Non Surgical Debulking

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Teeth undergo non-surgical debulking of periapical tissues.

**Intervention Names:**

- Procedure: Non surgical debulking of periapical tissues

- Procedure: Non surgical debulking of periapical tissues with growth hormone application

**Label:** Non surgical debulking group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Teeth undergoes Growth Hormone application.

**Intervention Names:**

- Procedure: Growth hormone application

- Procedure: Non surgical debulking of periapical tissues with growth hormone application

**Label:** Growth hormone group

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Teeth undergo non-surgical debulking of periapical tissues with Growth Hormone application.

**Intervention Names:**

- Procedure: Non surgical debulking of periapical tissues with growth hormone application

**Label:** Non surgical Debulking & Growth hormone group

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Teeth undergo conventional root canal treatment without any additional intervention

**Intervention Names:**

- Procedure: Root canal treatment

**Label:** Control group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Non surgical debulking group

**Description:** Non surgical debulking of periapical tissues

**Name:** Non surgical debulking of periapical tissues

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Growth hormone group

**Description:** Growth hormone application during non-surgical root canal treatment

**Name:** Growth hormone application

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Growth hormone group

- Non surgical Debulking & Growth hormone group

- Non surgical debulking group

**Description:** Non-surgical debulking of periapical tissues with growth hormone application during non-surgical root canal treatment

**Name:** Non surgical debulking of periapical tissues with growth hormone application

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- Control group

**Description:** Teeth undergo conventional root canal treatment without any additional intervention

**Name:** Root canal treatment

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluation of non surgical root canal tratment healing according to CBCTPAI

**Measure:** Post operative CBCT scan

**Time Frame:** 6 months

**Description:** Evaluation of non surgical root canal tratment healing according to CBCTPAI

**Measure:** Post operative CBCT scan

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).

**Measure:** Post operative pain assesment

**Time Frame:** 24 hours

**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).

**Measure:** Post operative pain assesment

**Time Frame:** 48 hours

**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).

**Measure:** Post operative pain assesment

**Time Frame:** 72 hours

**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).

**Measure:** Post operative pain assesment

**Time Frame:** 96 hours

**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).

**Measure:** Post operative pain assesment

**Time Frame:** 120 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:- Necrotic teeth with apical periodontitis.

* Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility.
* Teeth with mature apices, root canal curvature between (0-10º) according to Schneider(9) and radii of curvature between 2 to 5 mm according to Pruett would be included in the study(10).
* Teeth with estimated working length of 20mm(±2mm) from the incisal edge as a reference point provided that the crown/root ratio was not compromised.
* Non-critical sized periapical lesion related only to one tooth of a 2 to 4mm diameter and score 3 when evaluated using the Cone Beam Computed Tomography Periapical Index Score (CBCTPAI)(11) , Table (1) presents the scoring scale of CBCT-PAI.
* Teeth located in anatomic areas in which enucleation of the periapical tissues may jeopardize nearby structures, such as the incisive foramen or nasal cavity should be at least 2 mm away from these structures.

Exclusion Criteria:

* Necrotic teeth with related periapical swelling or sinus tract.
* Teeth with previous root canal fillings and /or indirect coronal restoration.
* Teeth with abnormal root canal anatomy.
* Non-restorable teeth due to insufficient coronal tooth structure.
* Teeth with periodontal disease.
* Teeth with grade III mobility.
* Teeth with clinical evidence of a missing buccal bony plate over the periapical defect.
* Traumatized teeth with suspected root cracks, fractures, intrusive and extrusive injuries, previously avulsed or lateral luxation injuries.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Al Azhar University

**State:** Nasr City

**Zip:** 4450113

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007571

- Term: Jaw Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M13393

- Name: Periapical Diseases

- Relevance: HIGH

- As Found: Periapical Diseases

- ID: M10601

- Name: Jaw Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010483

- Term: Periapical Diseases

### Intervention Browse Module - Ancestors

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: HIGH

- As Found: Loss

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000006728

- Term: Hormones

### Misc Info Module

- Version Holder: 2024-05-31
