Comparative evaluation of soft tissue parameters and crestal bone changes around implants in sites with thin gingival phenotype using Advanced platelet rich fibrin (A-prf) versus Connective tissue graft (ctg) – A randomized clinical trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To compare and evaluate the width and thickness of keratinized tissue around implants using A-PRF vs CTG.
Study Overview
Brief Summary
A randomized controlled single blinded study will be conducted. A total number of 30 implants (NORIS, Int. Hex Ti. Tufted implant) will be placed in systemically healthy patients selected based on inclusion criteria. Informed consent will be taken from the patients.15 implants each will be randomly (with the aid of digital software available at: www.randomizer.org) allocated to test (Implant placement along with advanced -platelet rich fibrin) and control (Implant placement along with connective tissue graft) groups. Implants will be placed for both the groups. The peri-implant soft tissue thickness (STT) and keratinized tissue width (KTW) will be measured before implant placement (baseline) and at 3 months and 6 months postoperatively in the test and control groups. The crestal bone level changes are measured at 3months and 6 months. The measurements will be recorded by another operator to prevent the bias.
The sample size was calculated using G*Power 3.1.9.4 software. A sample size of 30 was estimated to be necessary to detect a large effect size (Cohen’s f=0.96) at an alpha of 5% and 80% power using independent samples t test.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Thin gingival phenotype with peri-implant mucosal thickness of 2mm or less and to have 1 missing tooth with the presence of 2 natural adjacent teeth.
- •Edentulous spaces with adequate ridge dimension for implant placement.
- •Absence of periapical pathology adjacent to the edentulous site.
- •Patients who are motivated, highly compliant, with good oral hygiene practice Patient should not have undergone a bone increasing procedure before or during the dental implant.
- •Patient should be free from any periodontal disease.
Exclusion Criteria
- •Patients with any systemic disease and medications that will interfere with treatment outcome.
- •Patients with known risk factors and risk modifiers which can influence the overall outcome of treatment were excluded from the study.
- •Pregnant and lactating women.
- •Persons who are not surgically fit for implant placement.
- •Presence of active periodontal disease.
Outcomes
Primary Outcomes
To compare and evaluate the width and thickness of keratinized tissue around implants using A-PRF vs CTG.
Time Frame: At baseline ,3 months and 6 months.
Secondary Outcomes
- To compare and evaluate the crestal bone levels using intra-oral periapical radiograph around implants placed using A-PRF vs CTG.
- To compare and evaluate the postoperative pain using visual analogue scale (VAS) in A-PRF group vs CTG group
Investigators
Ivaturi Naga Surya Akhila
GSL Dental College Rajahmundry