Skip to main content
Clinical Trials/NCT03413553
NCT03413553CompletedNot Applicable

Clinical Evaluation of Soft Tissue Augmentation Using Connective Tissue Graft and Platelet Rich Fibrin Around Immediately Placed Dental Implants Versus Immediate Implant Alone in Esthetic Zone

Abeer hassan sharafuddin1 site in 1 country20 target enrollmentStarted: March 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Pink Esthatic score

Study Overview

Brief Summary

The main hypothesis to be certified is that the addition of Subepithelial Connective Tissue Graft (SCTG) and Platelet rich Fibrin (PRF) to immediately placed implants will not significantly differ from immediately placed implant alone as regard gingival tissue stability.

Detailed Description

  • The primary objective Evaluation of connective tissue graft and platelet rich fibrin combined with immediate implant placement as an innovative option for more pink esthetic score, versus immediate implant alone.
  • The secondary objective Evaluation of patient satisfaction, width of keratinized mucosa, crestal bone level after the use of platelet rich fibrin and connective tissue graft combined with immediate implant versus immediate implant alone.
  1. Trial design:
  • A Randomized clinical trial.
  • Uni center: A trial will be carried out in one hospital.
  • Equal randomization: participants with equal probabilities for intervention.
  • Positive controlled: Both groups receiving treatment.
  • Parallel group study: Each group of patients receives a single treatment simultaneously.
  • Two assessors will assess the result (1st Assessor Perryhan.M.) & (2nd Assessor Nada Farouk)

Methods: Participants, interventions, and outcomes 9. Study setting: This study will be carried out on patients attending outpatient clinics in Oral Medicine, Diagnosis and Periodontology Department- Faculty of Dentistry Cairo University-Egypt. Post graduate Periodontology clinic 1st floor old section. Sirona dental units with LED light.

Preoperative measures (for both groups):

  • Phase I therapy (Supragingival scaling, subgingival debridement and oral hygiene instructions) should apply for the two groups before any surgical procedures.
  • 4 weeks later both groups will be examined to determine patient compliance with oral hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash* twice daily).
  • Radiographic measurements for marginal bone changes will be performed at baseline ( time of implant placement), three months and six months after implant placement or crown construction. Intra oral periapical radiographs performed with paralleling technique will facilitate bone level measurement on distal and mesial aspects of the implant . The highest coronal area of healing abutment will be recorded as a static reference line.
  • Width of keratinized mucosa measured at the line of mucogingival junction to the groove of free gingiva by Williams graduated periodontal probe 1 using the roll technique.
  • Ttissue biotype measured after anasthesia application and percing the keratinized gingiva perpendicular to the tooth against the alveolar bone. using Williams graduated periodontal probe .
  • Crestal bone level at the mesial and distal side of each implant was measured with using Kodak D speed films with a reference point before and after the surgical procedure.
  • Study casts for case study will be fabricated.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Inclusion criteria
  • •Patients with single or multiple non-restorable teeth in anterior or premolar area.
  • •Patient consent approval and signing.
  • •Intact labial/buccal bone plate.
  • •Patients should be free from untreated periodontal disease
  • •The recipient site of the implant is free from any pathological condition

Exclusion Criteria

  • •Systemic disease that contraindicates implant placement or surgical procedures.
  • •No or poor patient's compliance.
  • •Psychological problems.
  • •Pathology at the site of intervention.
  • •Pregnancy females.

Arms & Interventions

control group

Active Comparator

patient will receive immediate implant alone.

Intervention: immediate implant (Device)

intervention group

Other

immediate implant combined with connective tissue graft and platelet rich fibrin .

.

Intervention: immediate implant (Device)

intervention group

Other

immediate implant combined with connective tissue graft and platelet rich fibrin .

.

Intervention: connective tissue graft (Biological)

intervention group

Other

immediate implant combined with connective tissue graft and platelet rich fibrin .

.

Intervention: platelet rich fibrin (Biological)

Outcomes

Primary Outcomes

Pink Esthatic score

Time Frame: should be measured after 6 months below implant and graft placement

measured by clinical evaluation. The PES contains the following seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture at the facial aspect of the implant site.(26) It is measured as score (0-14), 0 is the lowest score and 14 is the highest score

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Abeer hassan sharafuddin
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Abeer hassan sharafuddin

Assistant lecturer of Oral Diagnosis, Oral Medicine and Periodontology, Queen Arwa University.- yemen

Cairo University

Study Sites (1)

Loading locations...

Similar Trials