Free Gingival Graft, Free Gingival Graft Volume Change, Keratinized Tissue
Conditions
Keywords
FGG, Delayed implant placement, Keratinized mucosa
Brief summary
Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement & simultaneous FGG or the conventional FGG protocol prior to implant placement.
Interventions
PROCEDUREOne Step Protocol
FGG will be done simultaneous with implant placement
PROCEDURETwo Steps Protocol
Conventional FGG protocol, prior to implant placement
Sponsors
Misr International University
International Dental Contiuing Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults at or above the age of 18. * Lower Posterior missing tooth/ teeth with minimal KT \< 2mm * Sufficient alveolar ridge length minimum 13-15 mm to IAN •. Sufficient alveolar ridge width minimum of 6 mm * Patients able to tolerate surgical periodontal procedures. * Patients who provided an informed consent and accepted the one-year follow-up period.
Exclusion criteria
* Patients diagnosed with periodontal diseases (Caton et al., 2018). * Current or previous smokers. * Pregnant and lactating females. * Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis. * Patients with active infection related to the site of implant. * Patients with parafunctional habits. * Patients with shallow vestibule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized tissue width | 12 months | Optical scans using intraoral scanner (Runyes® Model V5) were obtained at baseline, 3, 6 and 12 months post-operative for each patient. All the optical scans in standard tessellation language (STL) format, were imported to the digital software (Exocad). The best-fit algorithm was used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. KTW (mm) was measured from the preoperative MGJ to the new MGJ using distance measurement tool in the software. KTW measurements were taken at mesial, mid-buccal and distal sites on the buccal side of the implant, values at the three sites were then averaged. Difference between KTW baseline and KTW follow-up was then analyzed to present the changes in KTW |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bucco-lingual width bone changes | 12 Months | Postoperative CBCT evaluation was performed to all the recruited patients after 1 year to assess bucco-lingual (BL) bone width changes at three levels; at implant platform, 2mm and 5mm below the implant platform. To perform radiographic measurements and comparisons and to ensure standardization and reproducibility of the CBCT images, superimposition of DICOM file sets of each patient were done using Fusion module software (OnDemand3D ver, 1.0.9, Cybermed), which allowed sub-voxel accuracy. On the fusion module, both initial and postoperative volumes were superimposed and loaded at the same time. To measure the bucco-lingual (BL) bone width changes, the lingual surface of the implant was used as a reference point. A reference line was constructed along the lingual surface of the implant on the cross-sectional cut of the postoperative CBCT volume. Then, both baseline and postoperative CBCT volumes we |
| Survival Rate | 12 Months | Implant survival criteria were chosen according to Albrektsson et al. (1986). Surgical and prosthetic complications were also evaluated throughout the follow up timeline. |
| Total volume Changes | 12 months | Total volume change (mm3) was calculated at 3 and 12 months postoperative via surface volume analysis within the AOI for each patient. The best-fit algorithm (iterative closet point algorithm) was used to superimpose digital surface models, when comparing each AOI throughout out the follow up periods. To measure the volume gain, the solid preoperative scans were subtracted from the follow-up scans using the Boolean operations software tool. This step will produce a new virtual object representing the volume gained. A three-dimensional (3D) inspection and metrology software (Geomagic Control X, 2022.1.0) was used to calculate the volume gain in mm3 using the measure volume tool. |
Countries
Egypt
Outcome results
None listed