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Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence

Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05891990
Enrollment
36
Registered
2023-06-07
Start date
2023-10-01
Completion date
2025-12-30
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Implant

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

Interventions

PROCEDUREimmediate implant augmented with sticky tooth

* Topical anesthesia will be administered using an infiltration technique. * Atraumatic extraction will be done with the aid of periotome and Luxators. * The extraction socket will be debrided to remove any residual debris or granulation tissue. * Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection. * Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability. * The gap between the implant and the defect of the facial bone will be filled with the sticky tooth to reach enough buccal bone supported and then will be covered with absorbable barrier collagen membranes. * Finally, the flap will be repositioned and sutured.

PROCEDUREimmediate implant augmented with autogenous tooth graft

* Topical anesthesia will be administered using an infiltration technique. * Atraumatic extraction will be done with the aid of periotome and Luxators. * The extraction socket will be debrided to remove any residual debris or granulation tissue. * Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection. * Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability. * The gap between the implant and the defect of the facial bone will be filled with the autogenous demineralized dentin graft to reach enough buccal bone supported and then will be covered with collagen membranes. * Finally, the flap will be repositioned and sutured.

Sponsors

Halla Gamal Mohammed Esmail
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Radiographic width of bone labial to the implant1 yearAmount 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

MeasureTime frameDescription
Radiographic vertical bone changes1 yearVertical 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
Esthetic evaluation (The pink esthetic score)1 yearThe 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.
Implant stability6 monthsImplant stability will be measured using Ostell which has a scale ranges from 1 to 100, the higher the ISQ the more stability
Gingival Thickness1 yearGingival 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 changes1 yearThe 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
Midfacial recession1 yearCorono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth
Post-Operative Pain7 daysPain 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 Satisfaction1 yearThree Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure /
Post-operative swelling7 daysSwelling 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)
Width of the Keratinized Tissue1 yearIt will be evaluated from the gingival margin to the mucogingival junction (MGJ). The MGJ was assessed with roll technique

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026