Effect of Concentrated Growth Factors on Healing of Apicomarginal Defects: a Prospective Study

September 19, 2023 updated by: Wen Luo, West China Hospital
The persistent and chronic apical periodontitis has caused great difficulties for clinical physicians. Ensuring rapid and successful healing of the extensively damaged periapical region is a pressing issue that needs to be addressed. The treatment options include traditional apical surgery, simultaneous placement of bone powder and membrane after apical surgery, and simultaneous placement of sticky bone (bone powder mixed with concentrated growth factors gel) and membrane. However, high-quality evidence regarding these various treatment options is scarce. The purpose of this study is to compare the advantages and disadvantages of each treatment option, in order to guide clinical physicians in the application of apical surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective study will recruit 72 patients with chronic periapical periodontitis in their anterior teeth or premolars, all of which have received comprehensive root canal treatment. The patients will be randomly divided into four groups: Group A, which will undergo only apical surgery (including apicoectomy, inflammation debridement, and retrofilling of the root apex); Group B, which will undergo apical surgery plus bone powder; Group C, which will undergo apical surgery plus CGF (concentrated growth factors); and Group D, which will undergo apical surgery plus bone powder and CGF gel. Each group will consist of 18 patients, and all surgeries will be performed by the same experienced doctor. The participants will receive a 1-year follow-up with the assistance of a professional doctor, including questionnaire data and daily records of pain and swelling at 2, 6, and 12 hours and 7 days after the intervention. Cone-beam computed tomography (CBCT) images will also be taken before the surgery, immediately after the surgery, and at 2, 3, 4, 6, and 12 months post-surgery.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hainan
      • Haikou, Hainan, China, 570102
        • Recruiting
        • First Affiliated Hospital of Hainan Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old or above.
  • Tooth with significant symptoms or with root apex bone tissue destruction that cannot be treated by non-surgical methods.
  • The affected tooth is either an anterior tooth or a premolar.
  • The size of the lesion during preoperative cone beam computed tomography (CBCT) coronal acquisition is at least 6 mm but not more than 12 mm.
  • The affected tooth has undergone successful root canal treatment.
  • CBCT shows intact lingual side bone plate in the apical region, with only buccal alveolar bone defect present.
  • Good oral hygiene and compliance with medical instructions.

Exclusion Criteria:

  • Severe periodontal destruction, with over 1/3 of the root length absorbed by alveolar bone.
  • CBCT shows root fracture or root canal perforation.
  • After root apex surgery, crown-root ratio ≤1:1.
  • Presence of surgical contraindications, systemic and local factors that affect wound healing.
  • Pregnant women and females planning to conceive within the next two years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: only apical surgery group
which will undergo only apical surgery (including apicoectomy, inflammation debridement, and retrofilling of the root apex)
Experimental: bone substitute group
which will undergo apical surgery plus bone substitute
Other: bone substitute
Implanting bone substitute into the area of root apical bone defect
Experimental: concentrated growth factors group
which will undergo apical surgery plus CGF (concentrated growth factors)
Other: concentrated growth factor
Implanting concentrated growth factor into the area of root apical bone defect
Experimental: bone substitute and CGF group
which will undergo apical surgery plus bone substitute and CGF gel
Combination product: concentrated growth factor + bone substitute
Implanting concentrated growth factor + bone substitute into the area of root apical bone defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root apex healing status
Time Frame: up to 12 months

Measurements of postoperative apical bone healing were obtained using cone-beam computed tomography (CBCT) in horizontal, coronal, and sagittal planes, respectively.

Unit: mm
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain status
Time Frame: 7 days

Record the pain condition of patients postoperatively at 2, 6, and 12 hours, as well as daily for 7 days after the surgery through questionnaire surveys.

The pain scale is as follows:

0: No pain;

  1. (mild): Discomfort or pain that is felt but does not require medication;
  2. (moderate): Pain that is uncomfortable but tolerable, and can be effectively relieved with pain medication;
  3. (severe): Pain that is difficult to bear.
7 days
postoperative swelling
Time Frame: 7 days

Record the postoperative swelling of patients postoperatively at 2, 6, and 12 hours, as well as daily for 7 days after the surgery through questionnaire surveys.

Postoperative swelling score will be rated on the following scale:

0: No swelling;

  1. Mild swelling at the surgical site;
  2. Moderate swelling outside the surgical area;
  3. Severe swelling outside the treatment area.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH2200003294

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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