Clinical Evaluation of Soft Tissue Augmentation Using CTG and PRF Around Immediately Placed Dental Implants Versus Immediate Implant Alone in Esthetic Zone .

NCT03413553 | Completed

• 1 other identifier: 100100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Augmentation

Keywords

immediate implant; connective tissue graft; platelet rich fibrin

Outcome Measures

Primary Outcomes (1)

• Pink Esthatic score

  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

  should be measured after 6 months below implant and graft placement

Study Arms (2)

control group

ACTIVE COMPARATOR

patient will receive immediate implant alone.

Device: immediate implant

intervention group

OTHER

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

Device: immediate implant; Biological: connective tissue graft; Biological: platelet rich fibrin

Interventions

immediate implant DEVICE

Patient will receive immediate implant alone.

Also known as: post extraction immediate implant.

control group; intervention group

connective tissue graft BIOLOGICAL

patient will receive immediate implant with connective tissue graft and platelet rich fibrin

Also known as: sub epithelial graft

intervention group

platelet rich fibrin BIOLOGICAL

patient will recieve immediate implant combined with connective tissue graft and platelet rich fibrin

Also known as: platelet concentrate

intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60.
• 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

You may not qualify if:

• Smokers
• 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.

Sponsors & Collaborators

• Abeer hassan sharafuddin: lead
• Cairo University: collaborator

Study Sites (1)

Abeer Hassan Sharafuddin

Cairo, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of Oral Diagnosis, Oral Medicine and Periodontology, Queen Arwa University.- yemen

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 29, 2018
• Study Start: March 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: January 15, 2020
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

EG (1)