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NCT Number: NCT06592079

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Immediate implant and connective tissue graft

Procedure

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.

Immediate implant with connective tissue graft and bone graft

Procedure

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 outcomes

  1. Volumetric Analysis of Mid-facial recession

    Time frame: Preoperative,3months,6months and 12 months

    3d viewer will be used to the the midfacial recession .

Secondary outcomes

  1. Volumetric analysis of Interdental papillae height

    Time frame: Preoperative , 3 months, 6 months and 12 months

  2. Bone formed labial to the implant

    Time frame: Preoperative and 1 year

  3. Horizontal labio-palatal bone collapse

    Time frame: Preoperative and 1 year

  4. Vertical crestal bone level changes

    Time frame: Preoperative and 1 year

  5. Gingival biotype

    Time frame: Preoperative, 6 months and 12 months

  6. Volumetric analysis of buccal contour

    Time frame: Preoperative,3months,6months and 12 months

  7. Horizontal labio-palatal bone collapse

    Time frame: (Preoperative and 1 year)

  8. Full mouth bleeding score (FMBS)

    Time frame: Preoperative, 6months and 12 months

    (0,1,2,3) 0:normal gingiva, 1: No bleeding , 2:bleeding on probing, 3:tendency to spontaneous bleeding.

  9. Pain and discomfort

    Time frame: At 1,3 and 7 days after the surgery

    will be assessed using the visual analog scale VAS as recorded by the patient 1, 3 and 7 days after the surgery. The patients will mark the pain perception in a non-numerical 100 mm line ranging from "no pain=0" (left) to "very painful=100" (right). It will be given a numerical value by measuring in millimeters the distance from the left end of the line .

  10. Full mouth plaque score (FMPS)

    Time frame: Preoperative, 6 months and 12 months

    0 : no plaque scored at gingival margin

    1: Plaque scored at gingival margin FMPS: Number of sites scored with plaque/Number of sites evaluated x 100

  11. Pink Esthetic Score

    Time frame: at 12 months

    PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture. The peri-implant mucosa will be evaluated by the seven index points.The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value.

Study contacts

Contact information is provided by the study sponsor or research team.

Norai Ahmed Zayed, Masters Degree

CONTACT

[email protected]

+201221444954

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Oct 15, 2024

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.