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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.

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03334994
Enrollment
18
Registered
2017-11-07
Start date
2018-01-01
Completion date
2020-02-02
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Dental Implants Connective Tissue Graft Esthetic Zone

Keywords

Immediate dental implant, Connective tissue graft, Esthetic zone.

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.

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.

Interventions

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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Facial gingival levelUp to 6 monthsFGL 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

MeasureTime frameDescription
Patient satisfactionUp to 6 monthPost-Surgical Patient Satisfaction Questionnaire (PSPSQ). The patient questionnaire evaluates patients' perception and subjective admiration of the final result of the treatment
Tissue biotypeUp to 6 monthsThickness of the peri-implant mucosa around the implant
Pink esthetic scoreUp to 6 monthsseven 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
Pain scoreUp to 12 daysVisual 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
Bleeding on probingUp to 6 monthsBleeding was provoked by sweeping the peri-implant mucosal sulcus using a periodontal probe.
Probing depthUp to 6 monthsdistance from the peri- implant mucosal margin to the bottom of the peri-implant sulcus
Probing attachment levelUp to 6 monthsdistance from the base of the peri-implant sulcus to the implant shoulder using periodontal probe at four sites
Width of keratinized mucosaUp to 6 monthsdistance from the mucogingival junction (MGJ) to the gingival margin

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026