Ridge Preservation Using Collagen Sponge Alone or Combined with Xenograft: a Clinical and Histological Trial

NCT06896097 | Completed DMC

• 1 other identifier: P-ME-21-06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

24 patients had a treatment plan for extraction of non restorable single rooted maxillary tooth and will be subjected to one of three groups after tooth extraction Group (I): including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket, till crestal bone level and socket sealing will be done with a new layer of collagen sponge(superficial collagen layer) and criss-cross suture to stabilize the graft in place. Group (II): including 8 patients, preservation of extraction sockets will be done with collagen sponge alone and criss-cross suture. Group (III): control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss-cross suture.

Conditions

Ridge Preservation

Outcome Measures

Primary Outcomes (1)

• Ridge preservation using collagen sponge alone or combined with xenograft clinical and histological

  evaluate and compare the clinical outcomes to width and height of socket preservation using the Biologically-oriented Alveolar Ridge Preservation (BARP) versus Collagen Sponge (CS), all compared to negative control

  4 months

Study Arms (3)

Group I

EXPERIMENTAL

including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge (deep collagen layer) and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket and socket sealing will be performed with a new layer of collagen sponge (superficial collagen layer) and criss-cross suture to stabilize the graft in place

Procedure: Ridge preservation

Group II

EXPERIMENTAL

including 8 patients, preservation of extraction sockets will be done with collagen spong alone and criss-cross suture

Procedure: Ridge preservation

Group III

EXPERIMENTAL

control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss -cross suture

Procedure: Ridge preservation

Interventions

Ridge preservation PROCEDURE

extraction of non restorable tooth in a traumatic way and socket preservation with the selected group

Group I; Group II; Group III

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a single rooted maxillary tooth that had a treatment plan of extraction as; endodontic complication, root fracture, trauma, or advanced carious lesions.
• Teeth with or without periapical lesions not affecting buccal wall integrity.
• Patients age (18 - 60) years old.
• Patients with clinical periodontal health on an intact periodontium and adequate volume that allow for implant placement after follow-up period.
• Pristine extraction socket (type I socket).

You may not qualify if:

• Patients with any systemic condition that may affect surgical and healing process.
• Patients with active acute infection related to teeth of interest.
• Pregnant females.
• History of malignancy or radiotherapy for malignancy in the past 5 years.
• History of active bone metabolic disease.
• Patients taking or were taking medications that may affect bone turnover such as bisphosphonates.
• Patients with buccal bone thickness less than 1 mm that necessitate regeneration and flap elevation. 7
• Smoker patients who reported tobacco use in the past 5 years.
• The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Faculty of Dental Medicine for Girls

Cairo, Cairo Governorate, 11511, Egypt

Location

Study Officials

• Zienab Shalaby

  Faculty of Dental Medicine for Girls

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral medicine, periodontology, diagnosis and radiology Department faculty of Dental Medicine Al-Azhar University

Model Details: The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program, patients will be subjected to extraction of primary maxillary single rooted tooth and socket preservation will be done by collagen sponge alone or combined with xenograft

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: March 26, 2025
• Study Start: August 2, 2022
• Primary Completion: July 29, 2023
• Study Completion: January 2, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)