## Protocol Section
### Identification Module
**NCT ID:** NCT06435754

**Brief Title:** Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial

**Official Title:** Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial

#### Organization Study ID Info
**ID:** 110589
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

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

**Overall Status:** NOT_YET_RECRUITING

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

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Norai Ahmed Mohamed Zayed

**Investigator Title:** Dentist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone.

**Detailed Description:** The aim of this randomized clinical trial is to assess the volumetric and radiographic ridge contour changes following alveolar ridge preservation using Vestibular socket preservation in patient with type II fresh extraction sockets, versus ice cream cone technique.

In patients needing extraction in anterior maxilla with type II sockets, there will be no difference between the Vestibular socket preservation and ice cream cone technique regarding the changes in alveolar ridge contour.

### Conditions Module

**Conditions:**

- Alveolar Ridge Preservation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Alveolar ridge preservation following atraumatic extraction using Vestibular Socket preservation.

**Intervention Names:**

- Procedure: Intervention group Vestibular Socket Preservation

**Label:** Intervention group Vestibular Socket Preservation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Alveolar ridge preservation following atraumatic extraction using ice cream cone technique.

**Intervention Names:**

- Procedure: Control Group ice cream cone technique

**Label:** Control group ice cream cone technique

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group Vestibular Socket Preservation

**Description:** After atraumatic extraction Vestibular access horizontal incision will be made at the socket site, at the mucco-buccal fold. Subperiosteal tunnel will be created from the facial aspect of the socket orifice and extending apically until the extent of the vestibular access incision. A cortical shield will be introduced from the vestibular incision through the tunnel and the Socket will be filled by xenograft . Apical cut will be made at the palatal aspect to free the pedicle flap connective tissue and the pedicle flap will be raised using periosteal elevator and rotated and rolled occlusally to seal the socket and sutured using interrupted sutures . The primary palatal flap will be sutured in place over the donor site palatally using interrupted sutures.

**Name:** Intervention group Vestibular Socket Preservation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Control group ice cream cone technique

**Description:** After atraumatic extraction Collagen barrier membrane will be shaped as an ice cream cone and placed in the extraction socket lining the buccal tissues. The socket will be filled with Demineralized Bovine Bone Matrix DBBM.The upper part of the membrane will be used to cover the socket and will be stabilized by interrupted sutures using prolene sutures of size 6-0

**Name:** Control Group ice cream cone technique

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Soft tissue linear buccal distance will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark)

**Measure:** Linear buccal distance (mm)

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** Radiographic assessment using Cone Beam Computed Tomography to assess the labiopalatal alveolar ridge width reduction and changes in the height of the socket buccal and lingual ridges. Cone Beam Computed Tomography (CBCT) (Carestream Health, CS 8100 3D System) will be performed preoperative, baseline and 6 months postoperative.

**Measure:** Changes in the height of the socket buccal and palatal ridges (mm)

**Time Frame:** 6 months

**Description:** Labiopalatal volumetric ridge contour analysis will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark) and scans will be superimposed on each other.

**Measure:** Labiopalatal volumetric ridge contour analysis (mm)

**Time Frame:** 6 months

**Description:** Patient satisfaction will be evaluated using questionnaires during the 2 weeks after ARP.

**Measure:** Patient satisfaction (Yes/No)

**Time Frame:** 2 weeks

**Description:** The severity of subjective pain and swelling will be evaluated using the visual analog scale (VAS) score (score range = 0-10, with 0 reflecting no pain and swelling), and durations of pain and swelling will be investigated during the 2 weeks after ARP

**Measure:** Pain (1-10)

**Time Frame:** 2 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults from the age of 18 - 40 years
* Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar
* Type II sockets will be selected as revealed by Cone beam computed tomography (CBCT).
* Intact gingival tissue with at least 2mm keratinized tissue
* Absence of any systemic disease or drugs that contraindicate oral surgery using Modified
* Cornell Medical Index .
* Patients accepts to provide informed consent

Exclusion Criteria:

* Pregnant and lactating females.
* Smokers as smoking is a contraindication for any plastic periodontal surgery.
* Patients with BOP\>15%.
* Patients with periodontal diseases .
* Handicapped and mentally retarded patients.
* Patients undergoing radiotherapy.
* Presence of systemic disease that would affect wound healing.
* Presence of active infection with soft tissue communication.

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** norai.zayed@dentistry.cu.edu.eg

**Name:** Norai Zayed, Masters

**Phone:** 01221444954

**Role:** CONTACT

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
