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

F

Faculty of Dental Medicine for Girls

Status

Completed

Conditions

Ridge Preservation

Treatments

Procedure: Ridge preservation

Study type

Interventional

Funder types

Other

Identifiers

NCT06896097
P-ME-21-06

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

24 participants in 3 patient groups

Group I
Experimental group
Description:
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
Treatment:
Procedure: Ridge preservation
Group II
Experimental group
Description:
including 8 patients, preservation of extraction sockets will be done with collagen spong alone and criss-cross suture
Treatment:
Procedure: Ridge preservation
Group III
Experimental group
Description:
control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss -cross suture
Treatment:
Procedure: Ridge preservation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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