## Protocol Section
### Identification Module
**NCT ID:** NCT06412705

**Brief Title:** Vit D and Post-extractive Bone Turnover

**Official Title:** The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial

#### Organization Study ID Info
**ID:** VITD-01
#### Organization
**Class:** OTHER
**Full Name:** Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
### Status Module
#### Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-10-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-05
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aims of the study was to correlate the extent of the dimensional alveolar bone changes after tooth extraction and contextual guided bone regeneration with serum vit D levels in 14 patients. Moreover, at 4 months, a small bone sample was collected in order to correlate histological and immunohistochemical parameters of bone with vit D serum levels.

**Detailed Description:** The study included 14 patients requiring tooth extraction and subsequent post-extraction bone regeneration with heterologous graft material of porcine origin. Four months after extraction, dental implants were placed, and insertion torque values (ITV) and implant stability quotients (ISQ) were recorded. During implant placement, a small bone sample was collected for histological analysis. The aim of the study was to analyze the correlation between serum vitamin D levels and post-extraction bone volume contraction, collagen type I (Col1A1), osteocalcin, osteopontin, runt-related transcription factor 2 (Runx2), ITV, ISQ, Newly Formed Bone Tissue (NFBT).

### Conditions Module

**Conditions:**

- Vitamin D Deficiency

- Alveolar Bone Loss

- Alveolar Bone Resorption

**Keywords:**

- Dental Implants, Alveolar Bone Loss, Alveolar Process

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 14

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The present arm received tooth extraction and guided bone regeneration (performed with xenograft porcine material and collagen barrier membrane). After 4 months, a dental implant was inserted.

**Intervention Names:**

- Procedure: Tooth extraction, guided bone regeneration and dental implant

**Label:** Tooth extraction and bone regeneration

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Tooth extraction and bone regeneration

**Description:** The arm received tooth extraction and contextual guided bone regeneration. After 4 months, a dental implant was inserted.

**Name:** Tooth extraction, guided bone regeneration and dental implant

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Volumetrical changes of alveolar bone after tooth extraction measured by superimposition of two intraoral scans. The first was registered before the extraction of the tooth. The second was registered after 4 months (before inserting implant). The parameter used to measure the dimensional alveolar bone change is called "Integrated Distance" and it is expressed in mm3.

**Measure:** Dimensional alveolar bone changes

**Time Frame:** From extraction to implant insertion (4 months)

**Description:** Evaluation of new formed bone tissue performed by histomorphometric methods.

**Measure:** Evaluation of new formed bone tissue

**Time Frame:** Time of implant insertion: 4 months after extraction

**Description:** Evaluation of Total Calcified Tissue composed by the residual bone substitute utilized for regeneration plus the NFBT. The evaluation was performed by histomorphometrics methods.

**Measure:** Evaluation of Total Calcified Tissue (TCT)

**Time Frame:** Time of implant insertion: 4 months after extraction

**Description:** quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.

**Measure:** Expression of Collagen A1

**Time Frame:** Time of implant insertion: 4 months after extraction

**Description:** quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.

**Measure:** Expression of Osteocalcin

**Time Frame:** Time of implant insertion: 4 months after extraction

**Description:** quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.

**Measure:** Expression of Osteopontin

**Time Frame:** Time of implant insertion: 4 months after extraction

**Description:** quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.

**Measure:** Expression of Runx-2

**Time Frame:** Time of implant insertion: 4 months after extraction

**Description:** Evaluation of Implant Stability Quotient after the implant insertion. The measurement was performed with "Osstell" system (W\&H)

**Measure:** Evaluation of Implant Stability Quotient (ISQ)

**Time Frame:** Time of implant insertion: 4 months after extraction

**Description:** Evaluation of Implant Torque Value at the implant insertion performed with the surgery implant device.

**Measure:** Evaluation of Implant Torque Value (ITV)

**Time Frame:** Time of implant insertion: 4 months after extraction

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female adult (≥ 18 years old)
* Patients willing to participate and to attend the planned follow-up visits

Exclusion Criteria:

* Absence of Type 1-Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
* History of leukocyte dysfunction and deficiencies
* History of neoplastic disease requiring the use of radiation or chemotherapy
* History of renal failure
* Metabolic disorders such as osteoporosis and correlated vit D or antiresorptive medications assumption
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* History of uncontrolled endocrine disorders
* Alcoholism or any drug abuse
* History of immunodeficiency syndromes
* Smoker of 10 cig per day, cigar equivalents or tobacco chewers
* Conditions or circumstances which in the opinion of the investigator would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability
* Mucosa disease such as erosive lichen planus
* Residual post-extraction site with intact bone walls
* History of local irradiation therapy
* Persistent intraoral infection

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Roma

**Country:** Italy

**Facility:** Studi Odontoiatrici Luigi Canullo

**State:** RM

**Zip:** 00100

#### Overall Officials

**Official 1:**

**Affiliation:** Studi Odontoiatrici Luigi Canullo

**Name:** Luigi Canullo

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001361

- Term: Avitaminosis

- ID: D000003677

- Term: Deficiency Diseases

- ID: D000044342

- Term: Malnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000055093

- Term: Periodontal Atrophy

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5141

- Name: Bone Resorption

- Relevance: HIGH

- As Found: Bone Resorption

- ID: M18747

- Name: Alveolar Bone Loss

- Relevance: HIGH

- As Found: Alveolar Bone Loss

- ID: M17551

- Name: Vitamin D Deficiency

- Relevance: HIGH

- As Found: Vitamin D Deficiency

- ID: M4660

- Name: Avitaminosis

- Relevance: LOW

- As Found: Unknown

- ID: M6879

- Name: Deficiency Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25306

- Name: Malnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4589

- Name: Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M28025

- Name: Periodontal Atrophy

- 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

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001862

- Term: Bone Resorption

- ID: D000016301

- Term: Alveolar Bone Loss

- ID: D000014808

- Term: Vitamin D Deficiency

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
