Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence
- Conditions
- Immediate Implant
- Interventions
- Procedure: immediate implant augmented with sticky toothProcedure: immediate implant augmented with autogenous tooth graft
- Registration Number
- NCT05891990
- Lead Sponsor
- Halla Gamal Mohammed Esmail
- Brief Summary
Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft for management of Cases With Labial Plate Dehiscence
- Detailed Description
In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of tooth-derived granules in combination with platelet-rich fibrin ("sticky tooth") and autogenous tooth graft in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
-
Non-restorable teeth in the esthetic zone with a defect of labial bone.
- Teeth with no acute inflammation.
- Patients are free from any systemic condition that may affect the healing.
- Availability of bone apical and palatal to the socket to provide primary stability
- Good oral health.
- Willingness to sign the informed consent form.
- Heavy smoker (> 10 cigarettes/day)
- Pregnant females
- Contraindication for Implant surgery.
- Patients with poor oral hygiene.
- Acute inflammation in the site of implantation and adjacent tissue.
- A history of radiotherapy in the head or neck region.
- Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group immediate implant augmented with sticky tooth sticky tooth preparation: * patient's venous blood will be collected using a 21 g needle with a butterfly handle. * The blood in the test tubes will be centrifuged at 700 rpm for 3 min for women and 4 min for men because of a different hematocrit. * The liquid PRF fraction will be collected using a sterile syringe. It gently will be mixed with the demineralized dentin granules and allowed for five-ten minutes for polymerization in order to produce a sticky tooth. Control group immediate implant augmented with autogenous tooth graft Autogenous demineralized dentin graft preparation * Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation. * The pulp will be removed, using a root canal instrument. Subsequently, the remaining dentin will be cut into pieces. These pieces of dentin will be ground using a bone mill to produce dentin particles. * The sorted particles will be immersed in 70% ethanol and 4% H2O2 in a sterile container to remove any soft tissue remnants, bacteria, and smear layer. * Tooth particles will be demineralized using 0.6N HCl for 30 minutes to expose the dentine organic matrix. * After demineralization, the materials will be washed with phosphate-buffered saline (PBS) and dried with sterile gauze.
- Primary Outcome Measures
Name Time Method Radiographic width of bone labial to the implant 1 year Amount of bone labial to the implant will be measured perpendicular to the vertical line of the implant surface at the implant neck level or the top of the buccal bone (which is regarded as 0 mm), 3 mm and 6 mm apical to the implant neck Each measurement will be recorded at different times
- Secondary Outcome Measures
Name Time Method Width of the Keratinized Tissue 1 year It will be evaluated from the gingival margin to the mucogingival junction (MGJ). The MGJ was assessed with roll technique
Implant stability 6 months Implant stability will be measured using Ostell which has a scale ranges from 1 to 100, the higher the ISQ the more stability
Radiographic vertical bone changes 1 year Vertical bone height will be measured. Measurement will be taken at highest point of the remaining labial/buccal plate of bone using the implant neck as a reference point. Each measurement will be recorded at different times and the difference between pre and post-operative measurements will be determined as the gain in labial/buccal vertical bone dimension
Midfacial recession 1 year Corono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth
Gingival Thickness 1 year Gingival thickness will be evaluated 2 mm below the gingival margin with a short needle for and silicon disk stop. The needle will be inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface was reached. The silicone disc stop was then mounted in close contact with the gingival tissue surface. The insertion depth was assessed with a digital caliper accurate to the nearest 0.1 mm
Radiographic horizontal bucco-palatal bone changes 1 year The bucco-palatal width of the alveolar bone will be measured perpendicular to the long axis of the alveolar bone; the 3 measurements will be the coronal width (CW), middle width (MW), and apical width (AW). Each measurement will be recorded at different times
Esthetic evaluation (The pink esthetic score) 1 year The pink esthetic score will be calculated on the parameters defined by (Fürhauser et al. 2005). Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14.
Post-Operative Pain 7 days Pain will be assessed post-surgically using the Visual Analogue Scale (VAS) with numbers from 0 to 10 score zero represented no pain while score 10 represented the worst pain imaginable
Post-Operative patient's Satisfaction 1 year Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure
/Post-operative swelling 7 days Swelling will be assessed post-surgically using the Verbal Rating Scale (VRS) (García et al. 2008):
* Absent (no swelling),
* Slight (intraoral swelling at the operated area),
* Moderate (moderate intraoral swelling at the operated area) and
* Intense (intensive extraoral swelling extending beyond the operated area)