Clinical Evaluation of the Impact of Socket Preservation Using Collagen-Based Clot Retention Compared to Conventional Methods on Wound Healing Following Tooth Extraction in Patients Requiring Tooth Extraction
Comparing clinical outcomes and soft tissue healing in atraumatic tooth extraction with and without the use of Collacone collagen wound dressing
Design
Parallel-group, single-blind clinical trial. Participants are non-randomly assigned to two intervention groups (use of clot-preserving collagen) and control (no use of clot-preserving collagen).
Settings and conduct
The study will be conducted at the Orthodontics and Oral Surgery departments of Shahid Beheshti University of Medical Sciences, Dental School. It will involve atraumatic tooth extractions, with soft tissue measurements and evaluation of healing outcomes at 2 and 4 weeks post-extraction.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients requiring bilateral premolar extractions due to orthodontic treatment; informed consent given.
Exclusion criteria: Systemic diseases (e.g., diabetes); history of infection, abscess, or uncontrolled oral conditions; use of immunosuppressive drugs or antibiotics; smoking; non-consent
Intervention groups
Intervention group: Patients in the intervention group will receive collagen clot-preserving material in the socket of the extracted tooth.
Control group: Patients in the control group will not receive any material in their socket.
Clinical Evaluation of the Impact of Socket Preservation Using Collagen-Based Clot Retention Compared to Conventional Methods on Wound Healing Following Tooth Extraction in Patients Requiring Tooth Extraction
Public title
Socket Preservation with Collagen and Its Impact on Post-Extraction Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people without systemic diseases
Adults aged 18 to 65 years
Patients undergoing simple tooth extraction
Patients who are candidates for extraction of bilateral premolars for orthodontic treatment
Patients who provided full and informed consent to participate in the study
Exclusion criteria:
People who are prohibited from performing dental procedures
History of allergy to collagen or related substances
Presence of active oral infections
Using immunosuppressive drugs or antibiotics
Smoking
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Actual sample size reached:
16
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The treatment boxes are sealed with 10-digit codes, and each code contains either the original treatment (clot-preserving collagen) or the alternative treatment (no clot-preserving collagen). The researcher will ensure that patients are completely unaware of their treatment by closely monitoring the treatment process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
At baseline (immediately post-extraction), and at 14 and 28 days after the procedure.
Method of measurement
Wound closure and presence of any signs of infection or inflammation.
Secondary outcomes
1
Description
Pain level
Timepoint
At baseline (immediately post-extraction), and at 14 and 28 days after the procedure.
Method of measurement
Visual Analogue Scale
2
Description
Infection rate
Timepoint
At baseline (immediately post-extraction), and at 14 and 28 days after the procedure.
Method of measurement
Clinical evaluation for signs of infection such as redness, swelling, pus, or increased pain at the extraction site.
3
Description
Patient satisfaction
Timepoint
At baseline (immediately post-extraction), and at 14 and 28 days after the procedure.
Method of measurement
5-point Likert scale, where 1 is "very dissatisfied" and 5 is "very satisfied."
4
Description
Swelling
Timepoint
At baseline (immediately post-extraction), and at 14 and 28 days after the procedure.
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: The tooth extraction was performed conservatively and bilaterally. On one side, the dental socket was managed using natural collagen (Collacone, Botiss Biomaterials, Germany). For this purpose, after administering local anesthesia with (Persocaine-E; Daroupakhsh, Tehran, Iran), the periodontal ligaments were separated using a periosteal elevator, and the tooth was extracted conservatively using universal forceps (Aesculap Co, USA) with vertical and rotational pressure. In the intervention group, a piece of Collacone with dimensions (e.g., 10 × 10 × 5 mm, if specified) was placed inside the dental socket. The socket opening was then closed using 4-0 Vicryl absorbable sutures (Ethicon, Johnson & Johnson, NJ, USA) in a horizontal mattress technique.
Category
Treatment - Surgery
2
Description
Control group: The same surgical and suturing procedures were followed, but no collagen material was applied.Postoperative care instructions, including oral hygiene guidelines, dietary recommendations, and pain management with Gelofen (Ibuprofen 400 mg, Daana Pharma, Iran), were provided. Sutures were removed one week postoperatively.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Shahid Beheshti University of Medical Sciences