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OpenTrials
Completed

NCT Number: NCT05670067

Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity

In the study immediate implant is placed in the anterior region with autogenous bone grafting from the maxillary tuberosity in one group and in the other group immediate implant is placed with xenograft .IN both groups soft tissue grafting is done using connective tissue assessment of buccal bone thickness and soft tissue will be done 6 months post operative

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Ain Shams University

Cairo, Egypt

About this study

immediate implant will be placed in the anterior region with autogenous graft from the maxillary tuberosity and in the other group immediate implant will be laced with xenograft soft tissue grafting using sub-epithelial connective tissue will in both groups assessment of buccal bone thickness is the primary outcome of the study, while volumetric assessment of the soft tissue and patient satisfaction are the secondary and tertiary outcome the assessment of all outcome will be 6 months post operative the extraction socket in which the implant will be placed are class I&II

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Systemically healthy patients (American Society of Anesthesiologists I; ASA I).
  • Age range (20-40) years.
  • Good compliance with the plaque control instructions following initial therapy.
  • Patients diagnosed with bone defect in the maxillary anterior esthetic zone (class 1 & 2)
  • Availability for follow up and maintenance program.

Exclusion criteria

  • Peri apically infected teeth
  • Presence of smoking habit.
  • Presence of occlusal interferences.
  • Pregnant females.
  • Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).

Treatment and study plan

maxillary tuberosity bone graft (autogenous graft)

Procedure

the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration

Bone graft (xenograft)

Procedure

xenograft is bone graft material that is obtained from porcine, bovine or equine source

Primary outcomes

  1. buccal bone thickness

    Time frame: at baseline and 9 months

    measuring the buccal bone thickness using CBCT

Secondary outcomes

  1. soft tissue assessment using pink esthetic score

    Time frame: 9 months post opertive

    The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency, Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14

  2. patient satisfaction

    Time frame: after 9 months

    questionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Localized Alveolar Ridge Reconstruction and Soft Tissue Augmentation Using a Triple Graft From the Maxillary Tuberosity Simultaneous With Immediate Implant Placement ( a Randomized Clinical Clinical Study)

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 4, 2023
Registry last updated
Mar 11, 2025

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.

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