Soft Tissue Atrophy
Conditions
Brief summary
Aim of the study The rationale for conducting the present study is to evaluate the efficacy of porcine collagen matrix in the management of defective width of keratinized mucosa around dental implant.
Detailed description
Therefore, the primary objective is to evaluate the integration of porcine collagen matrix with the recipient site and measuring the amount gained of keratinized mucosa. The secondary objective is to assess the pink esthetic score around dental implant following porcine collagen matrix compared to the free gingiva graft.
Interventions
PROCEDUREAll dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).
Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture. Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
surgery and give medication
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Patient between 25-50 years old. 2. Remaining bone height of more than 8 mm, remaining bone width of 6 mm 3. Inadequate keratinized soft tissue \<2 mm (13). 4. Favorable pattern of occlusion. 5. Good oral hygiene. 6. Patient ability to comply with the required recall visits.
Exclusion criteria
1. Insufficient bone width (less than 6 mm) mesiodistal or buccolingually. 2. Patients having any uncontrolled systemic disease which could affect bone healing. 3. Patients treated with radiotherapy to the head and neck area within the past 12 months. 4. Heavy Smokers (more than 20 cigarette per day) according to WHO. 5. Inability or unwillingness to return for follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical | 3 months | Surgical Operation Time: Duration of implant site preparation and graft fixation. Unit: Minutes. Time Frame: During surgery. |
| Clinical Evaluation: | 3 months | Wound Healing Status: Presence or absence of soft tissue dehiscence or wound infection. Unit: Yes/No. Time Frame: Post-operative follow-up visits. |
| clinical | 3 months | Implant Stability: Implant stability measured using Resonance Frequency Analysis (Osstell). Unit: Implant Stability Quotient (ISQ). Time Frame: Immediately post-placement and at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical periodontal parameters | 3 months | Plaque Index (PI): Dental plaque accumulation around implants measured using the Plaque Index. Unit: PI score. Time Frame: 3 months post-operatively. |
| clinical parameters | 3 months | Probing Depth (PD): Peri-implant probing depth to assess peri-implant tissue health. Unit: mm. Time Frame: 3 months post-operatively. |
| radiographic | 6 months | 1. Implant Position Accuracy Description: Evaluation of the accuracy of dental implant placement in relation to adjacent teeth and surrounding vital anatomical structures using Cone Beam Computed Tomography (CBCT). Unit of Measure: Deviation distance in millimeters (mm) Time Frame: At 6 months post-implant placement 2. Crestal Bone Level Changes - Mesiodistal Description: Measurement of crestal bone level changes in the mesiodistal direction around the dental implant using CBCT. Unit of Measure: Millimeters (mm) Time Frame: At 6 months post-implant placement 3. Crestal Bone Level Changes - Buccolingual Description: Measurement of crestal bone level changes in the buccolingual direction around the dental implant using CBCT. Unit of Measure: Millimeters (mm) Time Frame: At 6 months post-implant placement |
| clinical perodontal parameters | 3 months | Clinical Attachment Level (CAL): Measurement from cemento-enamel junction to base of peri-implant sulcus/pocket. Unit: mm. Time Frame: 3 months post-operatively. |
| clinical periodontal parameters | 3 months | Keratinized Tissue Width (KTW): Width of keratinized mucosa around implant site. Unit: mm. Time Frame: 3 months post-operatively. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORmohamad sa haichal, bachelor
faculty of dentistry Mansoura university
Outcome results
None listed