faculty of dentistry Mansoura university ,
Al Mansurah, 022, Egypt
NCT Number: NCT06643468
The goals of this clinical trial study is to evaluate the additive effect, of using ALB-PRF membrane combined with two different types of bone grafts with putty form in treatment of peri-implant bony defects around immediate dental implant within the maxillary esthetic zone.
Researchers will compare the ALB- PRF membrane extracted from patient blood with synthetic collagen membrane in addition to the putty form bone graft The main questions it aims to answer are:
Is the ALB-PRF is considered suitable alternative to synthetic collagen membrane in GBR techniques? also, growth factors releasing form ALB-PRF can continue over 21 days.
Participants will:
receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. Also, in other hand participant will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane. and compered with participants receive the same bone and implant technique except for ALB-PRF membrane instead of collagen.
Interested in participating?
Request Info20 year–60 year
All sexes
Interventional
Not applicable
Al Mansurah, 022, Egypt
I) Patient selection Participants will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University. All patients will be informed regarding the study nature of the surgical procedures, time of treatment, benefits, the suspected risk or complications and follow-up schedule visits and requested to sign a written consent. This study will be performed after getting approval by the ethics committee of the Faculty of Dentistry at Mansoura University.(A02090230M)
Inclusion criteria
Exclusion criteria
Study design:
Selected participants will receive forty implants that will be placed immediately after extraction of unrestorable maxillary tooth/ teeth in the aesthetic zone. According to the type of the used bone graft and membrane, the participants will be randomly divided into 4 equal groups:
Group I: will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and collagen as membrane. Group II: will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and collagen as membrane.
Group III: will include 10 patients, in which participants will receive immediate implant with nano-crystalline putty hydroxyapatite as bone graft and ALB- PRF as membrane. Group IV: will include 10 patients, in which participants will receive immediate implant with beta-tricalcium phosphate + calcium sulphate as bone graft and ALB- PRF as membrane.
Procedures:
Pre-surgical phase:
Surgical phase:
Post-surgical instruction:
Loading on implant will be done four months after the implant insertion.
Evaluation:
I) Clinical Evaluation: all the following clinical parameters will be reassessed at 0,6,12 months.
Will be evaluated according to pink esthetic score (PES).
The distance between the base of the pocket and the gingival margin will be measured using a graduated plastic probe.
Plaque index will be taken as an indicator for the patient oral hygiene.
Using Resonance Frequency Analysis device (Osstell), implant stability will be assessed in both groups at baseline, 6 months , and 12 months postoperative
II) Radiographic Evaluation:
Using cone beam CT (CBCT) scan, the changes in the marginal bone level and the thickness of buccal plate will be measured at baseline, 6 months and 12 months postoperative.
III) Laboratory analysis :
Samples will be collected using sterile paper strip at day of surgery, one, two, four, and eight weeks postoperatively for analysis of the growth factors concentration according to manufacture instruction using multiplex immunoassay.
Statistical analysis:
The data will be collected and statistical analysis will be done
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: clinical parameters will be reassessed at plate will be measured at baseline, 6 months and 12 months postoperative.
Evaluate if the ALB-PRF membrane in combination with the two tested putty form bone graft materials play a role in acceleration of soft tissues healing.
assessment of soft tissue healing which evaluated according to pink esthetic score (PES).
The pink esthetic score evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
Time frame: baseline, 6 months and 12 months postoperative
Hard tissue healing evaluation; Using cone beam CT (CBCT) scan, the changes in the marginal bone level and the thickness of buccal plate will be measured at baseline, 6 months and 12 months postoperative.
CBCT will be evaluated and assessed by subtraction methods to notice the gained and loosed bone in millimeters.
Time frame: baseline, 6 months and 12 months postoperative.
The distance between the base of the pocket and the gingival margin will be measured using a graduated plastic probe.
Time frame: baseline, 6 months , and 12 months postoperative
Using Resonance Frequency Analysis device (Osstell®), implant stability will be assessed in both groups
Time frame: baseline, 6 months , and 12 months postoperative
Modified bleeding index will be taken as an indicator gingival inflammation.
Time frame: one, two, four, and eight weeks postoperatively
Samples will be collected using sterile paper strip at day of surgery, one, two, four, and eight weeks postoperatively for analysis of the growth factors concentration according to manufacture instruction using multiplex immunoassay
Mansoura University
Other
Evaluation of the Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form in the Treatment of Peri-Implant Bony Defects Around Immediate Dental Implants in the Maxillary Aesthetic Zone.
Acronym: ALB-PRFE-PRF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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