Comparison of two approaches to rebuilding gum tissue around dental implants
| ISRCTN | ISRCTN10502178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10502178 |
| Secondary identifying numbers | 3167/S.M |
- Submission date
- 06/02/2022
- Registration date
- 22/02/2022
- Last edited
- 15/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Following tooth extraction, within the first week after removing the tooth, there is a vast amount of gum loss, especially at the outer surface of bone. In order to compensate for the loss of volume, a number of surgical procedures may be necessary. Including those increasing dimensions of soft tissue, to gain additional volume. The gold standard for this type of procedure is the use of connective tissue which is generally taken from the hard palate. As this procedure leaves a second surgical site for the patient healing may be impaired. It is desirable to reduce complications and shorten the healing phase. Various soft tissue substitutes were evaluated in the past to replace autogenous tissue. Although clinical data demonstrated promising results for various substitute materials when used for gain of keratinized tissue or recession coverage, tissue augmentation in terms of volume gain cannot be achieved predictably using these collagen materials. In order to replace the harvesting of autogenous tissue, a volume stable collagen matrix were developed allowing for soft tissue volume augmentation, the porous network of Geistlich Fibro-Gide® supports formation of new connective tissue and stability of the collagen network in submerged healing. In vivo animal models have shown good integration of xenogeneic collagen matrix (Geistlich Fibro-Gide®) into the surrounding soft-tissue while maintaining stability. With Geistlich Fibro-Gide® additional harvest site is avoided, patient morbidity is reduced.
Who can participate?
Patients aged 20 years or above who have a dental implant with soft tissue recession
What does the study involve?
Control group: 15 sites will be treated by coronal advancement flap with subepithelial connective tissue graft.
Test group: 15 sites will be treated by coronal advancement flap with xenogeneic collagen matrix (Geistlich Fibro-Gide®).
What are the possible benefits and risks of participating?
Benefits:
1. Covering of the peri-implants soft tissue recessions
2. Increasing width and thickness of keratinized tissue
3. Enhancing/improving esthetic satisfaction
Risks:
Potential Graft failure could happen in case of lack of commitment to post-operative instructions
Where is the study run from?
The department of Periodontology
Faculty of Dental Medicine
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
September 2019 to July 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Lama Al Saleh
alsalehlama9@gmail.com
Contact information
Scientific
Department of Periodontology
Damascus University
Damascus
-
Syria
 ORCID ID |
0000-0002-3114-4651 |
|---|---|
| Phone | +963 949269577 |
| alsalehlama9@gmail.com |
Scientific
Department of Periodontology
Damascus University
Damascus
-
Syria
| Phone | +963 945927791 |
|---|---|
| suleimandayoub@gmail.com |
Study information
| Study design | Interventional randomized controlled split mouth trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparison of the peri-implant soft-tissue recession coverage and esthetic outcomes of two different approaches: xenogeneic collagen matrix (Geistlich Fibro-Gide®) and subepithelial connective tissue graft using the coronal advancement flap for the treatment of soft tissue recession |
| Study objectives | (Geistlich Fibro-Gide®) is an alternative to Connective Tissue Graft (CTG) due to its characteristics which are its volume stability, contains collagen, use, and indications like insufficient soft tissue volume and recession defects. Compared to CTG, it has proven a stable augmented soft tissue both in terms of quality and quantity with the additional benefits of eliminating the donor site and lowering patient pain perception when compared to CTG. |
| Ethics approval(s) | Approved 03/09/2019, Medical research committee at Damascus University faculty of dental medicine (Mazzeh, Damascus, Syria; +963 40404840; Osama.aljabban@gmail.com), ref: 3167/S.M |
| Health condition(s) or problem(s) studied | Peri-implant soft tissue defects treatment |
| Intervention | The study contains 15 patients with bilateral soft tissue recession peri-implant ≥2mm in one implant at least in the upper or lower jaw, therefore 30 affected sites will be treated Control group: 15 sites will be treated by coronal advancement flap with a subepithelial connective tissue graft. Test group: 15 sites will be treated by coronal advancement flap with xenogeneic collagen matrix (Geistlich Fibro-Gide®) Follow up : 3 months Randomisation process: Coin Flip |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Recession depth at 2 weeks, month, 3 months measured using a periodontal probe |
| Secondary outcome measures | 1. Width and thickness of keratinized tissued measured using a periodontal probe at baseline and 3 months 2. Percentage of implant coverage measured using a periodontal probe at baseline and 3 months 3. Recession width measured using a periodontal probe at baseline and 3 months 4. Color and texture of treatment sites, ‘‘equal or not equal to surrounding native tissue’’ through visual observation and palpation at 2 weeks, months, and 3 months. 5. Subject esthetic satisfaction, (‘‘unsatisfied’’ to ‘‘very satisfied’’) on a five-point scale at 3 months 6. Subject pain or discomfort (‘‘no pain’’ to ‘‘extreme pain’’) on 10-cm visual analog scales at 2 hours, 24hrs, 48hrs, 72hrs and 1 week. |
| Overall study start date | 03/09/2019 |
| Completion date | 04/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 patients, 30 surgical sites. |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Patients with bilateral soft tissue recession peri-implant ≥2mm 2. Thin gingival biotype 3. Age ≥20 years old 4. No probing depths ≥5mm 5. Healthy implants measured by the lack of periimplantitis and mucositis 6. Good oral hygiene |
| Key exclusion criteria | 1. Unstable systemic diseases 2. Compromised immune system 3. Unstable bleeding disorders 4. History of radiation or cancer in the oral cavity 5. Use of intra-venous bisphosphonate or steroid medication 6. Use of tobacco products (1/2 pack per day) 7. Pregnant or breastfeeding women 8. Previous mucogingival surgery or implant placement within the past 6 months 9. Bone defects requiring grafting 10. Bad oral hygiene |
| Date of first enrolment | 15/09/2019 |
| Date of final enrolment | 20/06/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Faculty of Dental Medicine
Mazzeh
Damascus
-
Syria
Sponsor information
University/education
Faculty of Dental Medicine
Department of Periodontology
Mazzeh
Damascus
-
Syria
| Phone | +963 (0)112232152 |
|---|---|
| damasuniv@net.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/05/2022 |
|---|---|
| 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 peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
15/03/2022: The intention to publish date was changed from 15/03/2022 to 15/05/2022.
22/02/2022: Trial's existence confirmed by medical research committee at Damascus university
