Badly Broken Down Vital Teeth, Badly Broken Maxillary Premolars Indicated for Extraction
Conditions
Keywords
jumping gap, immediate implant placemnet, soft tissue around implant, soft tissue healing
Brief summary
Statement of the problem: Soft tissue healing following immediate implant placement is one of the major factors that affect implant restoration, function & success. Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.
Detailed description
Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region. Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in molar sites region requiring implant placement. They will be randomly allocated to three equal groups. Group A (test group, n=12) will receive immediate implants (grafting with PRF), group B (test group, n=12) will receive immediate implants (grafting with HAM) and group c (test group, n=12) will receive immediate implants (no grafting). After implant placement, soft tissue healing (1ry outcome) and postoperative pain (2nd outcome) will be assessed. The parameters will be assessed at baseline, every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
Interventions
PROCEDUREPRF
PRF membrane will be used for soft tissue grafting around implant
PROCEDUREHuman amniotic membrane
Human amniotic membrane will be used for soft tissue grafting around implan
PROCEDURENo grafting
No soft tissue grafting around implant
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding of outcome assessors and participants will be achieved as the different outcomes will be assessed for all groups by assessors other than the researchers doing the procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients at least 18 years old, with non-restorable first and second molars. 2. Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth. 3. Minimum alveolar Bucco-palatal dimension of 7 mm.
Exclusion criteria
1. Patients with known systemic diseases which can affect normal bone formation or blood coagulation. 2. Patients who are smokers. 3. Presence of signs of active infection or pus formation. 4. Absence or loss of buccal wall prior to implant placement. 5. Bad oral hygiene
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue healing | Baseline, every day for the first week, day after day second week, once in third and fourth week | Surface area/intraoral scanner |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post operative pain | Baseline, every day for the first week, day after day second week, once in third and fourth week | Visual analog scale: numerical scale in which 0 is no pain and 10 is maximum pain |
Countries
Egypt
Outcome results
None listed