Clinical trial NCT06525324: Comparision of Clinical Efficacy of Immediate Implants With T-PRF and Bone-graft Versus PRF and Bone-graft
Official title: Comparing The Effectiveness Of T-PRF And PRF With Bone-Graft[DMBM]TM Around Immediate Implants - A RANDOMISED CONTROL TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implants
Keywords: PRF with bone graft
T-PRF with bone graft
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The normal architecture of the alveolar process is altered by periodontitis, which also causes the loss of alveolar bone surrounding the teeth. Untreated periodontitis may cause teeth to become mobile and leads to loss of teeth.

In such cases, one of the treatment modalities is extraction of the tooth and placement of immediate implant which reduces the waiting period. And due to the resorption of alveolar ridge the bone graft will be used along with T-PRF and PRF.

So this study aims at the placement of immediate implants along with T-PRF with bone graft and PRF with bone graft.

Detailed description: Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. And their will be resorption of alveolar process due to periodontitis . In such compromised cases, to achieve bone augmentation around immediately placed implants a new modality of using platelet rich fibrin (PRF) along with graft material has gained considerable interest.

Successful clinical results have been reported with L-PRF, but some physicians worry about a possible health hazard with glass-evacuated blood collection tubes with silica activators. O'Connell described the unavoidable silica contact. The silica particles in the tube, although dense enough to sediment with the red blood cells, are small enough for a fraction to remain colloidally suspended in the buffy coat, fibrin, and platelet-poor plasma layers therefore, these particles might reach the patient when the product is used for treatment.

Recently use of titanium tubes in the preparation of PRF showed more polymerized fibrin formation with longer resorption in tissues as titanium seems to be more effective in activating platelets than silica and also eliminates the possible silica contamination.

The use of T-PRF(Titanium PRF) along with xenograft creates a block graft with high concentrated growth factors, platelets and leucocytes which enhance development of bone and eliminates the possible silica contamination.

Hence, the aim of the study is to compare the effectiveness of T-PRF with xenograft \[DMBM\] and PRF with xenograft \[DMBM\] around immediate implants.

Eligibility criteria: Inclusion Criteria:

1. Patients between 18-55 years of age.
2. Presence of non-restorable teeth (maxillary or mandibular) due to trauma, decayed, mobility, root resorption, root stumps, root fracture, over retained deciduous tooth, endodontic or periodontal failure in whom immediate implants can be placed.
3. Good oral hygiene.
4. Good patient compliance.
5. Class I extraction socket defects according to modified Elian et al 2021.

Exclusion Criteria:

1. Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
2. Intravenous and oral bisphosphonate therapy.
3. Patients who are psychologically unable to participate.
4. Pregnant and lactating participants with bone diseases
5. Patients on chemotherapy or radiotherapy
6. Alcohol or drug abuse.

Primary outcomes:
measure: Marginal Bone Level Using RVG and Grid.
timeFrame: Baseline , 3 months , 9 months
measure: Soft tissue healing
timeFrame: Baseline ,3 months , 9 months
measure: Bone fill using RVG with grid
timeFrame: 3 months , 9 months
measure: Bone dimensions using CBCT
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
References:
citation: Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Firatli E. In vivo evaluation of titanium-prepared platelet-rich fibrin (T-PRF): a new platelet concentrate. Br J Oral Maxillofac Surg. 2013 Jul;51(5):438-43. doi: 10.1016/j.bjoms.2012.08.003. Epub 2012 Aug 28.