Soft Tissue Healing During Alveolar Ridge Preservation

NCT06927453 | Active Not Recruiting DMC

• 1 other identifier: Soft Tissue Healing
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Statement of the problem: Alveolar ridge preservation after tooth extractions is considered a challenge in oral surgery daily practice. Dental extraction is a traumatic procedure which leads to loss of alveolar bone. The alveolar bone remodeling, which occurs after tooth extraction, leads to vertical and horizontal bone volume loss. Although placentally derived allografts have been widely applied in medical procedures over the past 100 years, their use in the dental field is relatively new. The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.

Conditions

Badly Broken Maxillary Premolars Indicated for Extraction

Keywords

Human amniotic Membrane (HAM); Alveolar ridge preservation; Soft tissue healing

Outcome Measures

Primary Outcomes (1)

• Soft tissue healing

  Surface area/intraoral Scanner in mm

  every day for the first week, day after day second week, once in third and fourth week

Secondary Outcomes (1)

• post operative pain

  every day for the first week, day after day second week, once in third and fourth week

Study Arms (2)

Acrylic splint .

ACTIVE COMPARATOR

●The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site covered with the custom acrylic splint.

No splint .

ACTIVE COMPARATOR

The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site will not be covered by splint.

Interventions

Acrylic splint PROCEDURE

The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site covered with the custom acrylic splint.

No splint PROCEDURE

The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site will not be covered

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who need simple teeth extractions.

You may not qualify if:

• Patients with inability or anticipated failure to maintain adequate oral hygiene.
• Pregnant or breast-feeding mothers.
• Any medical condition or therapy that can affect healing.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of oral and dental medicine , Suez university

Suez, Suez Governorate, 23568, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: blinding of outcome assessors and participants will be achieved as the different outcomes will be assessed for all groups by assessors other than the researchers doing the procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 15, 2025
• Study Start: January 7, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-01

Locations

EG (1)