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Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using CTG Around Immediate Dental Implants vs Immediate Dental Implants Alone in the Esthetic Zone.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334994
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Parryhan Mohamed Abdelsamie, Cairo University

Brief Summary:
Aim of current study to evaluate connective tissue graft combined with immediate implant placement as an innovative option for less facial gingival tissue recession, less pocket depth and less clinical attachment loss versus immediate implant alone.

Condition or disease Intervention/treatment Phase
Immediate Dental Implants Connective Tissue Graft Esthetic Zone Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant. Not Applicable

Detailed Description:

P: Adult patients with single or multiple non-restorable teeth in esthetic zone I: Immediate implant + Connective tissue graft. C: Immediate implant alone. O: Primary Outcome: Facial gingival level Secondary Outcome: Patient satisfaction, probing depth, probing attachment loss, tissue biotype, keratinized mucosal width and bleeding on probing.

P.M will select patients from the outpatient clinic of the Oral Medicine and Periodontology Department - Cairo University. Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The patients was randomly classified into two groups:

Group A: Patient will be treated with immediate implant alone. Group B: Patients will be treated with connective tissue graft combined with immediate implant.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Blinded participants: patient will be ensured by masking the instruments during the surgery. The patient will be informed of the steps of the surgery (as mentioned in the consent form) without getting into details. Blinding to the clinical, radiographic assessors is done by not involving them in sequence generation or allocation concealment or surgery performing.
Primary Purpose: Treatment
Official Title: Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in the Esthetic Zone. Randomized Controlled Trial.
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : February 2, 2020

Arm Intervention/treatment
Active Comparator: Control group: immediate implant alone
Patient will be treated with immediate implant alone.
Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.
Patients will be treated with connective tissue graft combined with immediate implant.

Active Comparator: (Group A) immediate implant alone
Patient will be treated with immediate implant alone.
Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.
Patients will be treated with connective tissue graft combined with immediate implant.




Primary Outcome Measures :
  1. Facial gingival level [ Time Frame: Up to 6 months ]
    FGL was evaluated by measuring the distance between the level of soft tissues and the lower border of the customized template that was used as a reference line at three readings mesially, mid-facially and distally.


Secondary Outcome Measures :
  1. Pain score [ Time Frame: Up to 12 days ]
    Visual analog scale was recorded every day for 12 days follow-up and the patient marks on the line the point they feel that it represents their response

  2. Patient satisfaction [ Time Frame: Up to 6 month ]
    Post-Surgical Patient Satisfaction Questionnaire (PSPSQ). The patient questionnaire evaluates patients' perception and subjective admiration of the final result of the treatment

  3. Tissue biotype [ Time Frame: Up to 6 months ]
    Thickness of the peri-implant mucosa around the implant

  4. Pink esthetic score [ Time Frame: Up to 6 months ]
    seven different variables: mesial papilla, distal papilla, facial soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture at the facial aspect of the implant site

  5. Width of keratinized mucosa [ Time Frame: Up to 6 months ]
    distance from the mucogingival junction (MGJ) to the gingival margin

  6. Bleeding on probing [ Time Frame: Up to 6 months ]
    Bleeding was provoked by sweeping the peri-implant mucosal sulcus using a periodontal probe.

  7. Probing depth [ Time Frame: Up to 6 months ]
    distance from the peri- implant mucosal margin to the bottom of the peri-implant sulcus

  8. Probing attachment level [ Time Frame: Up to 6 months ]
    distance from the base of the peri-implant sulcus to the implant shoulder using periodontal probe at four sites



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-55
  2. Patients with single or multiple non-restorable teeth in maxillary anterior or premolar area.
  3. Patients with adequate bone volume for the dental implant procedure.
  4. Patients who are compliant to oral hygiene measures.
  5. Patient consent approval and signing.

Exclusion Criteria:

  1. Heavy smokers.
  2. Systemic disease that contraindicates implant placement or surgical procedures.
  3. No or poor patient's compliance.
  4. Psychological problems.
  5. Pathology at the site of intervention.
  6. Pregnancy females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334994


Locations
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Egypt
Cairo University, Faculty of Dentistry.
Giza, Egypt, 12613
Sponsors and Collaborators
Cairo University
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Responsible Party: Parryhan Mohamed Abdelsamie, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03334994    
Other Study ID Numbers: 302017
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parryhan Mohamed Abdelsamie, Cairo University:
Immediate dental implant, Connective tissue graft, Esthetic zone.