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Study · Not a test of the peptide alone · 1997

9 results

A phase I/II clinical trial to evaluate a combination of recombinant human platelet-derived growth factor-BB and recombinant human insulin-like growth factor-I in patients with periodontal disease.

Howell TH, Fiorellini JP, Paquette DW, Offenbacher S, Giannobile WV, Lynch SE

Journal of periodontology1 Dec 1997Cited by 245 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone9

In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking IGF-1 (mecasermin).

  1. 01HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialSafety outcome

    In periodontal disease, PDGF-BB/IGF-I administration produced no identified local safety issues.

    In plain wordsIn periodontal disease, the PDGF-BB/IGF-I combination produced no identified local safety issues.

    Outcome
    Not applicableLocal safety issues
    Study

    n = 38

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    No local or systemic safety issues were found as a result of GF administration.
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  2. 02HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialSafety outcome

    In periodontal disease, PDGF-BB/IGF-I administration produced no identified systemic safety issues.

    In plain wordsIn periodontal disease, the PDGF-BB/IGF-I combination produced no identified safety issues affecting the whole body.

    Outcome
    Not applicableSystemic safety issues
    Study

    n = 38

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    No local or systemic safety issues were found as a result of GF administration.
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  3. 03HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialSafety outcome

    In periodontal disease, no patients developed antibodies to the administered PDGF-BB/IGF-I proteins.

    In plain wordsIn periodontal disease, no patients developed antibodies to the PDGF-BB/IGF-I proteins.

    Outcome
    Not applicableAntibodies to growth-factor proteins
    Study

    n = 38

    Analysis
    Primary
    Outcome group
    Immune response · Immune and inflammation

    Source sentences

    Summary
    No patients developed antibodies to the rhGF proteins.
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  4. 04HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialEfficacy outcome

    In periodontal disease, high-dose PDGF-BB/IGF-I yielded 42.3% osseous defect fill versus 18.5% in controls.

    In plain wordsIn periodontal disease, high-dose PDGF-BB/IGF-I filled more of the bone defect than controls.

    Outcome
    IncreaseHigh-dose osseous defect fill
    Study

    n: not reported in source

    Comparator
    Surgery or surgery plus vehicle
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    osseous defect fill
    42.3%
    HD-PDGF/IGF-I
    osseous defect fill
    18.5%
    controls

    Source sentences

    Summary
    This corresponded to an increase of 2.08 mm of new vertical bone height and 42.3% osseous defect fill in the HD-PDGF/IGF-I subjects versus only 0.75 mm and 18.5% gains in new bone height and osseous fill, respectively, in the controls.
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  5. 05HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialEfficacy outcome

    In periodontal disease, low-dose PDGF-BB/IGF-I did not increase defect fill compared with control.

    In plain wordsIn periodontal disease, low-dose PDGF-BB/IGF-I did not increase bone defect fill compared with control.

    Outcome
    No significant changeLow-dose defect fill
    Study

    n: not reported in source

    Comparator
    Surgery or surgery plus vehicle
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    LD-PDGF/IGF-I did not elicit increased defect fill compared to the control;
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  6. 06HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialEfficacy outcome

    In periodontal disease, low-dose PDGF-BB/IGF-I did not enhance periodontal regeneration versus controls.

    In plain wordsIn periodontal disease, low-dose PDGF-BB/IGF-I did not improve tissue regeneration compared with controls.

    Outcome
    No significant changeLow-dose periodontal regeneration
    Study

    n: not reported in source

    Comparator
    Surgery or surgery plus vehicle
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    In subjects treated with LD-PDGF/IGF-I, there were no enhancements in periodontal regeneration compared to controls.
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  7. 07HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialEfficacy outcome

    In periodontal disease, high-dose PDGF-BB/IGF-I significantly increased alveolar bone formation versus controls at re-entry.

    In plain wordsIn periodontal disease, high-dose PDGF-BB/IGF-I increased bone formation compared with controls.

    Outcome
    IncreaseHigh-dose alveolar bone formation
    Study

    n: not reported in source

    Comparator
    Surgery or surgery plus vehicle
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    New vertical bone height gain
    2.08 mm
    HD-PDGF/IGF-I at surgical re-entry
    New vertical bone height gain
    0.75 mm
    controls at surgical re-entry
    Osseous defect fill
    42.3%
    HD-PDGF/IGF-I at surgical re-entry
    Osseous defect fill
    18.5%
    controls at surgical re-entry
    P value for alveolar bone formation versus controls
    < 0.05 unitless
    HD-PDGF/IGF-I versus controls, surgical re-entry 9 months following drug delivery

    Source sentences

    Summary
    However, in patients treated with HD-PDGF/IGF-I, statistically significant increases in alveolar bone formation were noted as measured by surgical re-entry 9 months following drug delivery (P < 0.05).
    Summary
    This corresponded to an increase of 2.08 mm of new vertical bone height and 42.3% osseous defect fill in the HD-PDGF/IGF-I subjects versus only 0.75 mm and 18.5% gains in new bone height and osseous fill, respectively, in the controls.
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  8. 08HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialEfficacy outcome

    In periodontal disease, high-dose PDGF-BB/IGF-I yielded 2.08 mm of new vertical bone height versus 0.75 mm in controls.

    In plain wordsIn periodontal disease, high-dose PDGF-BB/IGF-I produced more new vertical bone height than controls.

    Outcome
    IncreaseHigh-dose vertical bone height
    Study

    n: not reported in source

    Comparator
    Surgery or surgery plus vehicle
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    new vertical bone height
    2.08 mm
    HD-PDGF/IGF-I
    new vertical bone height
    0.75 mm
    controls

    Source sentences

    Summary
    This corresponded to an increase of 2.08 mm of new vertical bone height and 42.3% osseous defect fill in the HD-PDGF/IGF-I subjects versus only 0.75 mm and 18.5% gains in new bone height and osseous fill, respectively, in the controls.
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  9. 09HumanNot a test of IGF-1 (mecasermin) aloneNon-randomized trialEfficacy outcome

    In periodontal furcation lesions, PDGF-BB/IGF-I treatment yielded 2.8 mm horizontal osseous fill.

    In plain wordsIn periodontal furcation lesions, PDGF-BB/IGF-I treatment produced 2.8 mm of horizontal bone fill.

    Outcome
    Not applicableFurcation horizontal osseous fill
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    horizontal osseous fill
    2.8 mm
    furcation lesions

    Source sentences

    Summary
    Furcation lesions, although limited in number, responded most favorably to treatment, with 2.8 mm horizontal osseous fill.
    3 context sentences
    Summary · context
    Thirty-eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split-mouth design.
    Summary · context
    Two dose levels were tested, 50 micrograms/ml each of rhPDGF-BB and rhIGF-I in a gel vehicle (LD-PDGF/IGF-I) and 150 micrograms/ml each of rhPDGF-BB and rhIGF-I plus vehicle (HD-PDGF/IGF-I).
    Summary · context
    Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle.

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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