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Completed

NCT Number: NCT06049823

Alveolar Ridge Preservation With Different Grafting Strategies

The aim of the present study was to compare the half-packed grafts that are covered with either a collagen or a nonresorbable membrane to the conventional alveolar ridge preservation procedures involving full-packed grafts and collagen membrane. The primary purpose was to evaluate the bone dimensional changes between the groups, and the secondary objective was to assess the potential contributing factors to clinical, radiographic and implant-related outcomes under different alveolar ridge preservation procedures.

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Key information

Conditions

Bone Resorption Bone Diseases Musculoskeletal Diseases

Age range

24 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Chang Gung Memorial hospital

Taipei, 105, Taiwan

About this study

Regarding different surgical approaches in alveolar ridge preservation, limited studies directly compare collagen and non-resorbable membrane, and the comparison between half- and full- grafting strategy in clinical and radiographic outcomes was still lacking. The comparable effect of dimensional preservation between groups was shown except for more radiographic bone gain in full-grafting group. Contributing factors, including thin bone thickness , vertical root fracture related sockets, non-molar sites and large BPD might attenuate the effect of ARP. At implant placement, similar results in bone quality and keratinized mucosal width was found in all groups, while thicker vertical mucosal thickness was obtained when using nonresorbable membrane. All surgical modalities in alveolar ridge preservation yield stable peri-implant health 1 year after implant placement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ≥ 20 years old
  • presence of one or more hopeless teeth requiring extraction and subsequent implant placement due to reasons such as crack tooth, vertical root fracture, endodontic failure, unrestorable caries and severe periodontitis
  • the extraction socket should have more than two walls for ARP, which includes type I-II sockets (Palatal/ lingual defects were also included)
  • participants should have a stable periodontal condition or history of periodontitis that is well-controlled with good oral hygiene. The pocket depth of the adjacent tooth around the socket should be less than 3 mm as assessed with a periodontal probe (Hu-Friedy, Chicago, IL, USA).

Exclusion criteria

  • heavy smokers consuming more than half pack of cigarettes daily
  • women who were pregnant, lactating, or planning to be pregnant
  • history of psychiatric disorders
  • uncontrolled and complicated medical conditions that might hinder wound healing or bone metabolism, including poorly controlled diabetes, autoimmune disorders, receiving current radiotherapy in the head and neck regions, taking bisphosphonate and other antiresorptive agents.

Treatment and study plan

Alveolar ridge preservation

Procedure

Different grafting strategy of alveolar ridge preservation with different sealing materials

Primary outcomes

  1. bone dimensional changes between the groups

    Time frame: 6-month healing period after alveolar ridge preservation

    Based on CBCT images, horizontal measurements by using AVIZO software (version 7.0, FEI). The measurements were repeated twice at a 2-week interval, and mean values were used for the final analysis (width or height in millimeters, mm):

    • Buccal bone plate thickness (BT) at 1 mm, 3mm, 5mm apical to the crest
    • Horizontal ridge width (HRW) at 1 at 1 mm, 3mm, 5mm apical to the crest
    • The change of HRW at 1, 3, 5 mm apical to crest (T2-T1).

    Vertical measurements in cross-sectional images:

    • Buccal bone height (BH)(mm)
    • Palatal/lingual bone height (PH)(mm)
    • The discrepancy between buccal and palatal/lingual height.(mm)
    • Midcrestal height (Mid-H)(mm)
    • The change of BH, PH, and Mid-H between immediate post-operative and 6 months later. (T2-T1)(mm).

Secondary outcomes

  1. Clinical and implant related outcomes

    Time frame: 6-month healing period after alveolar ridge preservation

    Other clinical and implant-related parameters with descriptions:

    • Demographic data
    • Keratinized mucosal width (KMW)(mm)
    • Vertical mucosal thickness (VMT): measured from the mucosal profile to the crest of the ridge using a periodontal probe after buccal full-thickness flap elevation (Hu-Friedy, Chicago, IL, USA)(mm)
    • Bone density: Lekholm and Zarb's classification as types 1, 2, 3, or 4
    • Insertion torque: recorded once the implant was placed at the anticipated level with primary stability (NCM)
    • Marginal bone level change(mm) Based on the results of the normality tests, one-way ANOVA followed by the Tukey HSD or Kruskal-Wallis test with post hoc Dunn's test was performed for intergroup comparisons. The Chi-square association test (X2) was used to compare categorical variables between groups. Univariate linear regression methods were performed to investigate the factors to the changes of ridge width and height.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Comparison of Half- and Full-Grafting Alveolar Ridge Preservation With Different Sealing Materials: A Three-arm Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2023
Registry last updated
Sep 22, 2023

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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