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OpenTrials
Completed

NCT Number: NCT06896097

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine for Girls

Cairo, Cairo Governorate, 11511, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ridge Preservation

Procedure

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

Primary outcomes

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

    Time frame: 4 months

    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

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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