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

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.

Study Overview

• Status: Completed
• Conditions: Ridge Preservation
• Intervention / Treatment: Procedure: Ridge preservation

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Faculty of Dental Medicine for Girls

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Ridge preservation; extraction of non restorable tooth in a traumatic way and socket preservation with the selected group
Experimental: Group II; including 8 patients, preservation of extraction sockets will be done with collagen spong alone and criss-cross suture	Procedure: Ridge preservation; extraction of non restorable tooth in a traumatic way and socket preservation with the selected group
Experimental: 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	Procedure: Ridge preservation; extraction of non restorable tooth in a traumatic way and socket preservation with the selected group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Principal Investigator: Zienab Shalaby, Faculty of Dental Medicine for Girls

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Actual): July 29, 2023
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: P-ME-21-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No