The use of patient’s own blood plasma derivative and palatal tissue graft in dental implant surgery
| ISRCTN | ISRCTN27670172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27670172 |
- Submission date
- 22/05/2023
- Registration date
- 25/05/2023
- Last edited
- 24/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental implants are widely used as a treatment to replace missing teeth. The thickness and width of keratinized tissues determine the viability of implants over time, their stability in function and aesthetics. The aim of this study is to assess and compare the use of platelet-rich fibrin (PRF) and sub-epithelial connective tissue graft (SCTG) at improving the condition of peri-implant soft tissues and enhancing aesthetic outcomes.
Who can participate?
Patients aged 18 to 60 years with thin gingival (gum) biotype (less than 1 mm) who are undergoing dental implantation and soft tissue augmentation around dental implants
What does the study involve?
Participants are randomly allocated to one of two groups. Group I receive delayed dental implantation with SCTG and PRF membrane during the second-stage implant surgery while Group II receive delayed dental implantation with SCTG during the second-stage implant surgery. The researchers assess the width and thickness of keratinized tissue, aesthetics, gingival blood flow, wound healing and cytokines in the fluid around the implant.
What are the possible benefits and risks of participating?
There will be no immediate direct benefits or risks to those taking part. Risks may be associated with the use of SCTG where there is a risk of developing necrosis of graft or suppuration (pus discharge). To eliminate risks, monitoring is carried out in the postoperative period.
Where is the study run from?
S.D. Asfendyarov Kazakh National Medical University in Almaty (Kazakhstan)
When is the study starting and how long is it expected to run for?
November 2020 to January 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Azhibekov Aibek, azhibekov.a@kaznmu.kz
2. Dr Menchisheva Yuliya, menchisheva.y@kaznmu.kz
Contact information
Scientific
Tole bi str.92
Almaty
050000
Kazakhstan
| Phone | +7 (0)87071178700 |
|---|---|
| azhibekov.a@kaznmu.kz |
Study information
| Study design | Interventional single-blinded randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Dental clinic, Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The use of platelet-rich fibrin in combination with sub-epithelial connective tissue graft in peri-implant soft tissue augmentation |
| Study objectives | The use of platelet-rich fibrin (PRF) and sub-epithelial connective tissue graft (SCTG) is an effective method in augmenting peri-implant soft tissue and improving gingival biotype and aesthetic outcomes which would help overcome the complications and increase patients’ satisfaction |
| Ethics approval(s) | Approved 26/05/2021, Research Ethics Committee of the Asfendiyarov Kazakh National Medical University (3rd floor, Tole bi str.92, Almaty, 050000, Kazakhstan; +8 (0)727 338 7024; lec.kaznmu@mail.ru), ref: 6(112) |
| Health condition(s) or problem(s) studied | Improvement of gingival thickness in patients with thin gingiva biotype who undergoing dental implantation |
| Intervention | Patients aged between 18 and 60 years with single or multiple non-restorable teeth were selected according to inclusion and exclusion criteria. The patients were randomly assigned to two groups using the method of random numbers; Group I received delayed dental implantation with SCTG and PRF membrane during the second-stage implant surgery while Group II received delayed dental implantation with SCTG during the second-stage implant surgery. After implant placement during second-stage implant surgery the SCTG that is de-epithelialized extraorally was harvested from the lateral part of the hard palate. Two horizontal and two vertical incisions are performed perpendicular to the mucosal surface, 1.0–1.5 mm deep. The mucosal defect on the donor part is closed with a collagen membrane and sutured. The graft is positioned on sterile gauze, moistened with a saline solution and de-epithelialized with a scalpel blade. The SCTG was put inside the vestibular pouch by mattress suture. In Group I the PRF membrane was prepared, where 10 ml of blood was obtained from the vein and transferred to the free anticoagulant tube. The blood sample was centrifuged at 700 g for 8 min and then the resultant fibrin clot was compressed in the PRF box to obtain the PRF membrane which was then applied over the SCTG. The feature of the surgical procedure was the formation of the flap and the shift of the initial keratinized tissues to the lingual side. The graft and PRF were stabilized with an absorbable suture (Vicryl 5-0). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Width of the keratinized tissue determined by measuring the distance between the mucogingival junction (MGJ) and free gingiva using a graduated periodontal probe at baseline, 3 and 6 months after the surgical procedure 2. Thickness measured by the cone-beam computed tomography (CBCT) with Ez3D-1 software (Vatech, Korea) before and 3, 6 months after the surgical procedure. The measurement of the thickness of mucous for determination of biotype was provided according to the following steps: before the examination in the vestibule site of the oral cavity dental cotton swabs were put, measurements are carried out in the frontal and sagittal dimensions in areas corresponding to the vestibular cortical plates of the root of the examined tooth, in the projection of the central axis of the tooth, from the top of the cortical plate to the mucogingival junction. |
| Secondary outcome measures | 1. Wound healing (epithelialization) measured using a cytological analysis at baseline, 3, 5, 7, and 10 days 2. Local immunity measured using a sandwich enzyme-linked immunosorbent assay (ELISA) for determination of the concentration of pro- and anti-inflammatory cytokines (IL-1β, TNFα and IL-4) in the peri-implant cervicular fluid at baseline, 1, 7 and 30 days 3. Gingival blood flow measured using a laser Doppler flowmetry (LDF) at baseline,1, 7 and 14 days 4. Esthetic result (mesial and distal papilla, soft tissue level, soft tissue contour, alveolar process deficiencies, soft tissue color, and texture) measured using a Pink esthetic score (PES) at 6 months after the prosthetic phase |
| Overall study start date | 25/11/2020 |
| Completion date | 03/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 110 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 18-60 years 2. Patients with single or multiple non-restorable teeth 3. Thin biotype of gingiva 4. Sufficient bone of alveolar ridge 5. Absence of untreated periodontal disease |
| Key exclusion criteria | 1. Pregnancy 2. Systemic diseases 3. Thick biotype 4. Insufficient bone |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 01/10/2022 |
Locations
Countries of recruitment
- Kazakhstan
Study participating centre
Almaty
050000
Kazakhstan
Sponsor information
University/education
Tole bi str.92
Almaty
050000
Kazakhstan
| Phone | +7 (0)727 338 70 90 |
|---|---|
| info@kaznmu.kz | |
| Website | https://kaznmu.edu.kz |
"ROR" |
https://ror.org/05pc6w891 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during the current study will be stored in a non-publicity available repository of Asfendiyarov Kazakh National Medical University. The data will be stored: 1. The thickness and width of keratinized tissue before in mm 2. The scores of PES 3. The level of TNF-α, IL-1β and IL-4 in pg/ml 4. The blood flux values according to LDF in A.U. (arbitrary unit) 5. Age/sex/nationality The process for requesting access: via a principal investigator mail request (Dr Azhibekov Aibek, azhibekov.a@kaznmu.kz) Dates of availability: until 03/01/2025 Consent from participants was obtained in written form in Kazakh language Comments on data anonymization: after enrollment, each patient received a unique identification number, in which all data were recorded accordingly. Personal identifying information provided by participants was separated and modified from the data, thus, outcome assessors and data analysts were blinded and had no access to information that could identify individual participants during or after data collection. |
Editorial Notes
24/05/2023: Study's existence confirmed by the Research Ethics Committee of the Asfendiyarov Kazakh National Medical University.
