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

NCT ID: NCT06896097

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2024-01-02

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.

Detailed Description

• Surgical Phase:

• Local infiltration anesthesia will be first administered to all patients in this study.
• Teeth will be extracted, using a flapless approach a traumatically as much as possible.
• Atraumatic extraction will start with dissection of periodontal ligaments in crestal part using 15C blades mounted over a round-handed blade to facilitate rotation without lacerating the soft tissue
• Then teeth will be luxated using micro-elevators and the final delivery movement will be done using forceps.
• Sockets will be thoroughly debrided using a curette, especially in case with periapical lesions, to ensure complete removal of granulation tissue.
• Assessment of sockets walls integrity will be done visually and using a UNC-15 periodontal probe. All patients will be allocated into one of the three study groups. 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group I

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

Group Type: EXPERIMENTAL

Ridge preservation

Intervention Type: PROCEDURE

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

Group II

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

Group Type: EXPERIMENTAL

Ridge preservation

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Ridge preservation

Intervention Type: PROCEDURE

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

Interventions

Ridge preservation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Faculty of Dental Medicine for Girls

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zeinab Shalaby

lecturer of oral medicine, periodontology, diagnosis and radiology Department faculty of Dental Medicine Al-Azhar University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zienab Shalaby

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dental Medicine for Girls

Locations

Faculty of Dental Medicine for Girls

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

P-ME-21-06

Identifier Type: -

Identifier Source: org_study_id