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Not yet recruiting NCT06592079

Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone

No phase Interventional Immediate Implants Connective Tissue Graft

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immediate implant and connective tissue graft, Immediate implant with connective tissue graft and bone graft.
Who it may be relevant to
Registry conditions: Immediate Implants Connective Tissue Graft. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone: A Randomized Clinical Trial

Overview

Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.

Detailed description

This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.

Interventions

  • Procedure Immediate implant and connective tissue graft
    Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.
  • Procedure Immediate implant with connective tissue graft and bone graft
    Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will placed to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Primary outcome measures

  • Volumetric Analysis of Mid-facial recession [Time frame: Preoperative,3months,6months and 12 months]
Secondary outcome measures (11)
  • Volumetric analysis of Interdental papillae height [Time frame: Preoperative , 3 months, 6 months and 12 months]
  • Bone formed labial to the implant [Time frame: Preoperative and 1 year]
  • Horizontal labio-palatal bone collapse [Time frame: Preoperative and 1 year]
  • Vertical crestal bone level changes [Time frame: Preoperative and 1 year]
  • Gingival biotype [Time frame: Preoperative, 6 months and 12 months]
  • Volumetric analysis of buccal contour [Time frame: Preoperative,3months,6months and 12 months]
  • Horizontal labio-palatal bone collapse [Time frame: (Preoperative and 1 year)]
  • Full mouth bleeding score (FMBS) [Time frame: Preoperative, 6months and 12 months]
  • Pain and discomfort [Time frame: At 1,3 and 7 days after the surgery]
  • Full mouth plaque score (FMPS) [Time frame: Preoperative, 6 months and 12 months]
  • Pink Esthetic Score [Time frame: at 12 months]

Eligibility criteria

Inclusion criteria

  • Patient-related criteria:
  • Adults at or above the age of 18.
  • Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
  • The failing tooth will have adjacent and opposing natural teeth.
  • Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
  • Able to tolerate surgical periodontal procedures.
  • Full mouth plaque and bleeding scores less than 20%.
  • Compliance with the maintenance program.
  • Provide informed consent.
  • Accepts the one-year follow-up period.

Teeth related criteria:

  • Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
  • Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
  • Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm

Exclusion criteria

  • Patients diagnosed with periodontal diseases.
  • Current or previous smokers.
  • Pregnant and lactating females.
  • Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
  • Patients with active infection related at the site of implant/bone graft placement.
  • Patients with parafunctional habits

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06592079 · 924

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗