Clinical practice
Healing time after bone grafting: reading the AmGraft IFU’s six-month minimum
The AmGraft IFU recommends at least six months of healing at the augmented site. How that sits beside general ridge-preservation guidance, and what the IFU leaves to the practitioner.
Vol. 1No. 043 min read4 references
How long to wait between grafting and the next surgical step is one of the most practical questions in regenerative dentistry. For AmGraft®, the Instructions for Use give a clear starting point. This article sets out exactly what the IFU says, how it compares with general guidance on ridge preservation, and what it leaves to the practitioner.
What the IFU says
The precautions section of the AmGraft IFU reads:1
Source 1
- 1 Ventas Bio Pte Ltd, 2022. AmGraft® Instructions for Use (date of information 2022-06)
A minimum period of 6 months’ healing is recommended at the augmented site using AmGraft®. The determination of the appropriate healing time has to be decided by the practitioner based on the diagnosis of the patient’s situation and condition. AmGraft® Instructions for Use, Precautions (date of information 2022-06)
There are two parts to this:
- A floor. Six months is the minimum recommended healing period at the augmented site.
- A clinical judgement above that floor. The practitioner decides the actual healing time for each patient, based on diagnosis and condition.
The IFU applies the same recommendation to all five of its listed clinical uses. It does not give a different interval for each indication, and it does not state the reasoning behind the six-month figure.1
How this compares with general ridge-preservation guidance
General guidance on socket grafting uses a shorter typical minimum. The 2019 European Workshop in Periodontology consensus recommends a minimum healing time that allows sufficient bone formation, “typically 3–4 months”. The same statement says that a longer healing time may be required because of the extraction site’s characteristics, the properties of the biomaterial used, and patient-specific systemic factors.2
Source 2
- 2 Tonetti MS et al, 2019. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology
Published studies also used a wide range of intervals. One systematic review of implant placement after ridge preservation reported healing periods from at least two to a maximum of twelve months across its included studies.3 A meta-analysis of autogenous tooth grafts recorded its outcomes between three and six months.4
Sources 3, 4
- 3 Fischer KR et al, 2022. Bone envelope for implant placement after alveolar ridge preservation: a systematic review and meta-analysis
- 4 Solyom E et al, 2023. The use of autogenous tooth bone graft is an efficient method of alveolar ridge preservation – meta-analysis and systematic review
These sources describe materials and protocols in general. The consensus statement itself points to the biomaterial’s properties as a reason to extend healing time.2 For a specific product, its IFU is the document that sets the recommendation.
If you have seen a shorter interval quoted
For AmGraft, the governing text is the IFU, and it recommends at least 6 months.1 If any material you have received quotes a shorter interval for AmGraft, the IFU takes precedence. Santé Maison’s materials follow the IFU wording.
Factors that call for special caution
The IFU lists diseases and therapies that adversely affect healing and call for special caution. They include but are not limited to:1
- acute and chronic infections at or around the operating area
- metabolic diseases such as non- or poorly controlled diabetes mellitus, hyperparathyroidism and osteomalacia
- disorders of calcium metabolism, or drugs that interfere with it
- treatment with steroids, antineoplastic drugs, immunosuppressives or high-dose glucocorticoids
- endocrinological bone diseases
- severe renal dysfunction or severe liver disease
- vascular impairment, autoimmune disease, radiotherapy and heavy smoking
These factors are relevant when deciding how far beyond the six-month floor to wait.
Two related precautions
- Not load-bearing. The IFU states that AmGraft is not intended to bear mechanical loads.1
- Mixing with other materials. The IFU states that the clinical outcome of mixing AmGraft with other bone graft materials is not known.1
Reporting
If you see an adverse outcome that may be attributable to the product, the IFU asks that it be reported promptly to Ventas Bio Pte Ltd or your distributor, and to your country’s competent authority.1 Our regulatory page explains how to report to Santé Maison.
References
- 1Ventas Bio Pte Ltd. AmGraft® Instructions for Use (date of information 2022-06).
- 2Tonetti MS, et al. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019. doi:10.1111/jcpe.13131
- 3Fischer KR, et al. Bone envelope for implant placement after alveolar ridge preservation: a systematic review and meta-analysis. Int J Implant Dent. 2022;8:56. doi:10.1186/s40729-022-00453-z
- 4Solyom E, et al. The use of autogenous tooth bone graft is an efficient method of alveolar ridge preservation – meta-analysis and systematic review. BMC Oral Health. 2023;23:226. doi:10.1186/s12903-023-02930-2
- AmGraft IFU
- healing time
- implant timing
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General education for dental professionals. Not advice on the care of any individual patient. Statements about AmGraft® follow its Instructions for Use (2022-06). AmGraft® is manufactured by Ventas Bio Pte Ltd and distributed by Santé Maison.
