Soft Tissue Mass Clinical Trial
Official title:
Alveolar and Soft Tissue Changes Surrounding Immediate Implant in the Mandibular Molars With and Without Using Sealing Socket Abutment Technique (Randomized Clinical Trial)
Verified date | April 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
First and second molar locations present major challenges when immediate implant placement is planned due to large extraction sockets that are difficult to seal without mucoperiosteal flap reflection which is less comfortable to patient and also crestal socket morphology not amenable to standard healing abutment which have circular shape and the possibility of high occlusal forces during function with complete provisional crown.Immediate implant placement without sealing socket abutment has several drawbacks, such as collapse of existing soft tissue and also it needs second stage surgery which is less comfortable to patient and chair time consuming for the operator.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 20, 2021 |
Est. primary completion date | February 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients with hopeless molars in the posterior area of the mandible. - Both sexes. - No intraoral soft and hard tissue pathology - No systemic condition that contraindicate implant placement Exclusion Criteria: - Very thin less than 0.5 mm or absent buccal plate. - Heavy smokers more than 10 cigarettes per day. - Patients with systemic disease that may affect normal healing. - Psychiatric problems - Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site - Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo Universty | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Soft tissue changes around implant | The PES comprises the following five variables: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue, color and texture at the facial aspect of the site. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14 at time of surgery and at the time of final prothesis.
All ten parameters are assessed by direct comparison with the contralateral tooth and a score of 2, 1, or 0 is assigned to all ten parameters. Thus, a maximum total PES of 10 can be reached which represents the optimum condition of the soft tissues of the rehabilitated site compared to the characteristics of the contralateral natural tooth. |
18 months | |
Secondary | marginal bone loss | The marginal bone on the buccal and lingual surface of the dental implant cannot be assessed with periapical views in millimeters from fixed point .
Using the same exposure parameter settings selected after a pilot test and images reconstructed with the same slice thickness and a cutting direction for histological matching to compare preoperative and postoperative. |
18 months |
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