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NCT Number: NCT07337837

Immediate Implant Placement in Type ii Socket by Vestibular Socket Therapy Using Collagen Membrane

Background: Immediate implant placement has become a routine and regular clinical practice. When the labial bone plate develops a dehiscence-type defect, delayed implant placement was recommended to give suitable amount of time for soft tissue thickening. However, it has a number of drawbacks, including a lengthy treatment period, the requirement for two surgical procedures, and a potential loss of facial contour. When immediate implant is placed with flap elevation and guided bone regeneration in type II socket, labial bone augmentation results were satisfactory, but in terms of soft tissue, it led to midfacial recession and loss of soft tissue contour, resulting in a compromised final esthetic result. To reduce these drawbacks, implant can be immediately placed by vestibular socket therapy using collagen membrane.

Aim of this study: To compare labial bone augmentation in immediate implant placement in type II extraction sockets by using collagen membrane placed by two different modalities.

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Key information

Conditions

Immediate Implant Type II Socket Vestibular Socket Therapy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both sexes with a single maxillary tooth (second bicuspid to second bicuspid) indicate for extraction due to fracture, badly decayed or endodontic lesionswith expected labial bone defect

Exclusion criteria

  • Pregnancy.
  • Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
  • Periodontal disease or gingival recession.
  • Heavy smokers (more than 30 cigarette / day).
  • Patients with poor oral hygiene

Treatment and study plan

vestibular socket therapy

Procedure

patients will undergo immediate implant placement and a mucoperiosteal tunnel will be made through a vestibular incision till labial orifice of the socket, a collagen membrane will be inserted under the tunnel and stabilized by membrane tacks. The space between the membrane and implant will be filled with mixture of allograft and xenograft bone material and any autogenous bone chips harvested from local surgical sites.

open flap surgery

Procedure

patients will undergo immediate implant placement combined with open flap surgery and labial plate augmentation.

Primary outcomes

  1. change in buccal bone thickness

    Time frame: baseline, 3 months, and 6 months

    CBCT will be taken for each patient and Labial bone thickness means the distance between the implant surface and the outer surface of bone

  2. change in buccal bone height

    Time frame: Baseline, 3 months, and 6 months

    Labial bone height means the distance between the apical end of the implant (which is projected on the baseline image) and the crest of the labial bone of both images

Secondary outcomes

  1. Volumetric change of buccal soft tissue contour

    Time frame: Baseline and 6 months

    The impressions will be taken using lab scanner to create digital surface models in Standard Triangle Language (STL) format, all STL files will be imported to a digital software. The best-fit algorithm will be used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow-up period.

  2. change in gingival esthetics

    Time frame: Baseline and 6 months

    The score incorporates seven domains: mesial papilla, distal papilla, soft tissue level, soft tissue contour, deficient alveolar process, soft tissue color, and texture. Each variable is scored from 0 to 2, with 2 being the best outcome. The total pink esthetic score will be calculated by adding the scores of the seven domains and ranged from 0 to 14 (best overall esthetic outcome).

  3. chang in Modified Sulcus Bleeding Index

    Time frame: Baseline and 6 months

    a score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant.

    Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Immediate Implant Placement in Type ii Socket by Vestibular Socket Therapy Using Collagen Membrane (Randomized Controlled Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

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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