The effect of different gum graft materials in preventing bone resorption after tooth extraction: a clinical trial
| ISRCTN | ISRCTN17187153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17187153 |
| Secondary identifying numbers | RUxFMqXf-UhdsIxv5-1DNV1zfn-BBJQx6TC |
- Submission date
- 21/06/2023
- Registration date
- 05/07/2023
- Last edited
- 20/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
After dental (tooth) extraction, bone resorption/remodelling is expected as a result of the healing process. However, this could have a negative impact on the dental implants used to replace missing teeth when this remodelling is too extensive or the residual bone is too thin. Ridge preservation techniques are interventions aimed at minimising this amount of bone resorption and therefore increasing the probability of successful implant placement without the need for any artificial bone graft. The aim of this study is to compare two treatments to achieve more efficient bone preservation after dental extraction.
Who can participate?
Healthy adult patients aged 18 to 90 years who require dental extraction where implant therapy is a feasible option
What does the study involve?
Participants are randomly allocated to one of two groups. In the control group, a xenograft (Bio-oss) in combination with an autogenous gingival (gum) graft will be used as a soft tissue seal. In the intervention group, a xenograft (Bio-oss) is used with another xenograft material (Muograft) as a soft tissue seal.
What are the possible benefits and risks of participating?
The main benefit of ridge preservation procedures is to increase the amount of available bone for dental implant placement at a later stage whereas the risks of these procedures are minimal or similar to any other oral surgery.
Where is the study run from?
Murcia University Teaching Hospital (Morales Meseguer) (Spain)
When is the study starting and how long is it expected to run for?
January 2022 to January 2024
Who is funding the study?
Universidad de Murcia (Spain)
Who is the main contact?
Dr Guillermo Pardo Zamora, gparza@um.es
Contact information
Principal Investigator
Universidad Murcia. Hospital Morales Meseguer
Facultad de Medicina.
Departamento Odontologia.
Avenida de los Velez
s/n
Murcia
30008
Spain
 ORCID ID |
0000-0002-6080-0216 |
|---|---|
| Phone | +34 (0)606064848 |
| gparza@um.es |
Scientific
Guys and St Thomas' Hospital
Dental Restorative Division
Periodontology Department
Great Maze Pond
London
SE1 9RT
United Kingdom
| ORCID ID |
0000-0003-2051-0668 |
|---|---|
| Phone | +44 (0)7864929396 |
| ruben.garciasanchez@gstt.nhs.uk |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of free gingival graft and connective tissue substitutes on the preservation of the ridge after tooth extraction: a clinical trial |
| Study objectives | The aim of this study was to test the main null hypothesis that there were no differences in alveolar preservation using xenograft material and Mucograft as a soft tissue seal vs the use of the same xenograft material and autogenous soft tissue graft as a seal vs the alternative hypothesis of a difference at 6 months. |
| Ethics approval(s) |
Approved 05/01/2022, University of Murcia Ethics Committee (Universidad De Murcia Campus de la Merced. Calle Santo Cristo, Murcia, 30001, Spain; +34 (0)868 88 36 14; comision.etica.investigacion@um.es), ref: RUxFMqXf-UhdsIxv5-1DNV1zfn-BBJQx6TC |
| Health condition(s) or problem(s) studied | Alveolar ridge preservation after dental extraction |
| Intervention | Patients were randomly assigned to the test or control group by balanced block randomization using a computer-generated table. Treatment assignment was concealed to the treating surgeon by opaque envelopes that were opened only after the completion of tooth extraction. In the control group, a xenograft (Bio-oss) in combination with an autogenous gingival graft will be used as a soft tissue seal. In the intervention group, a xenograft (Bio-oss) is used with another xenograft material (Muograft) as a soft tissue seal. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Soft tissue volumetric changes measured in plaster study models obtained at baseline, 3 and 6 months. Additionally, further measurements will be taken with a periodontal probe at baseline and 6 months to evaluate the location of certain anatomic landmarks using a custom-made prefabricated stent for each patient. |
| Secondary outcome measures | 1. Hard tissue volumetric changes assessed with intraoperative measures at the bone level at the time of dental extraction and at 6 months before placement of dental implants at those locations. A periodontal probe and calipers will be used to evaluate the location of certain anatomic landmarks using a custom-made prefabricated stent for each patient. 2. Probing pocket depth measured with a periodontal probe at baseline and 6 months 3. Gingival phenotype measured with a periodontal probe at baseline and 6 months 4. Plaque and gingival bleeding indexes measured with a periodontal probe at baseline and 6 months |
| Overall study start date | 05/01/2022 |
| Completion date | 01/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 30 |
| Key inclusion criteria | Healthy adult patients for which dental extraction was required and implant therapy was a feasible option to be offered/discussed |
| Key exclusion criteria | 1. Patients with medical history in which any dental intervention would be contraindicated such as uncontrolled diabetes, head and neck radiation for cancer treatment or current treatment with intravenous bisphosphonates 2. Presence of clinically symptomatic periapical radiolucencies, acute abscesses or chronic sinus tracts at the site of extraction 3. Heavy smokers (+10 cigarettes/day) 4. Pregnancy 5. Presence of active periodontal disease 6. Inability or unwillingness to return for follow-up visits |
| Date of first enrolment | 10/01/2022 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- Spain
Study participating centre
s/n
Murcia
30008
Spain
Sponsor information
Hospital/treatment centre
Calle de los Velez.
s/n
Murcia
30008
Spain
| Phone | +34 (0)868888584 |
|---|---|
| Bruno.negri@um.es | |
| Website | http://www.murciasalud.es/seccion.php?idsec=367 |
"ROR" |
https://ror.org/00cfm3y81 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- University of Murcia
- Location
- Spain
Results and Publications
| Intention to publish date | 06/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact factor journal. |
| IPD sharing plan | The data-sharing plans for the current study are currently unknown and will be made available at a later stage. |
Editorial Notes
20/02/2025: The intention to publish date was changed from 01/01/2025 to 06/01/2026.
03/07/2023: Study's existence confirmed by the University of Murcia Ethics Committee.
