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OpenTrials
Completed

NCT Number: NCT03334994

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

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.

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Key information

Conditions

Immediate Dental Implants Connective Tissue Graft Esthetic Zone

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University, Faculty of Dentistry.

Giza, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Heavy 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.

Treatment and study plan

Intervention group:(Group B) connective tissue graft combined with immediate implant.

Procedure

Patients will be treated with connective tissue graft combined with immediate implant.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2017
Registry last updated
Jun 9, 2020

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.