How soft tissue augmentation after tooth extraction improves implant health: findings from a clinical trial

ISRCTN	ISRCTN18692174
DOI	https://doi.org/10.1186/ISRCTN18692174
Secondary identifying numbers	0000

Submission date: 14/07/2024
Registration date: 15/07/2024
Last edited: 05/08/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
This study aims to compare the outcomes of dental implants placed at sites augmented with a novel cross-linked collagen matrix (Fibro-Gide®), traditional connective tissue grafts, or spontaneous healing following tooth extraction.

Who can participate?
Adults aged 18 years or older who have had a posterior mandibular (back tooth in jaw) extraction

What does the study involve?
Participants will be allocated to receive soft tissue augmentation with a xenogenic collagen matrix (XCM), connective tissue graft (CTG), or no biomaterial placed within the socket after tooth extraction. At 6 months after surgery, the participants will receive a dental implant.

What are the possible benefits and risks of participating?
This study will determine the effectiveness of using XCM and CTG in soft tissue augmentation before implant placement on the health of peri-implant tissues, compared to not applying any material within the socket. There is a risk of not achieving optimal results in some cases but the study team can manage these cases with alternative methods.

Where is the study run from?
Damascus University (Syria)

When is the study starting and how long is it expected to run for?
June 2023 to April 2024

Who is funding the study?
Damascus University (Syria)

Who is the main contact?
Dr Ammar Ibrahim AmmarIbrahimISRCTN@gmail.com

Contact information

Dr Ammar Ibrahim
Public, Scientific, Principal Investigator

Damascus
Damascus
00000
Syria

ORCID ID	0009-0003-0433-9108
Phone	+963 (0)992964458
Email	AmmarIbrahimISRCTN@gmail.com

Study information

Study design	Comparative interventional randomized controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	University/medical school/dental school
Study type	Prevention, Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Impact of soft tissue augmentation on peri-implant health post-extraction: a randomized controlled trial
Study objectives	Does the use of xenogenic collagen matrix or connective tissue graft, compared to spontaneous healing, affect the health of peri-implant tissues?
Ethics approval(s)	Approved 17/07/2023, Damascus University Ethics Committee (Damascus, Damascus, 0000, Syria; +963 (0)113341864; manager@hcsr.gov.sy), ref: 22486
Health condition(s) or problem(s) studied	Pre-implant placement soft tissue augmentation
Intervention	The method used for randomization was a closed envelope method. The envelopes were opened prior to the soft tissue augmentation procedure, allocating the patient into one of the three groups. Following extraction, the subjects underwent one of three randomly assigned treatments: soft tissue augmentation with connective tissue graft (CTG), xenogenic collagen matrix (XCM), or spontaneous healing (SH) without soft tissue augmentation. Six months subsequent to these interventions, dental implants were placed.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Pocket depth (PD) assessed using a periodontal probe gauged from the edge of the mucosa to the base of the pocket at two timepoints (baseline and 6 months after functional loading) at six distinct points around each implant, mesio-buccal (mb), buccal (b), disto-buccal (db), mesio-oral (mo), oral (o), and disto-oral (do), to ensure a thorough evaluation. 2. Marginal bone level (MBL) evaluated at two key intervals: initially at the time of implant insertion (baseline) and subsequently after a period of 6 months. For each dental implant (DI), standardized periapical radiographs were captured at baseline and at the 6-month mark, employing a paralleling apparatus. The quantification of marginal bone loss (MBL) involved measuring the span from the inaugural point of bone contact with the implant to the crest of the implant. The assessment of bone loss incorporated both the mesial and distal dimensions of each DI.
Secondary outcome measures	1. Plaque Accumulation Index (PAI): adapted from the methodology proposed by Löe and colleagues (LÖE et al., 1972). this index was evaluated using a periodontal probe at six points around each implant: mesio-buccal (mb), buccal (b), disto-buccal (db), mesio-oral (mo), oral (o), and disto-oral (do), to ensure a thorough evaluation at baseline and 6 months after functional loading. 2. Bleeding on Probing (BOP): a binary assessment indicating the presence or absence of bleeding, evaluated using a periodontal probe at six points around each implant: mesio-buccal (mb), buccal (b), disto-buccal (db), mesio-oral (mo), oral (o), and disto-oral (do), to ensure a thorough evaluation at baseline and 6 months after functional loading. 3. Mucosal recession (MR): distance from the edge of the restoration to the gingival margin was evaluated using a periodontal probe at the mid-buccal surface at baseline and 6 months after functional loading.
Overall study start date	23/06/2023
Completion date	23/04/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Both
Target number of participants	30
Total final enrolment	30
Key inclusion criteria	1. Had extraction sites that conformed to Type ST1 classification, as per Steigmann et al. (Steigmann et al., 2022), where both facial soft and hard tissues were preserved at levels consistent with the cementoenamel junction 2. Possessed at least 2 mm of keratinized tissue on the buccal aspect of the extraction site 3. Demonstrated commendable oral hygiene 4. Aged 18 years or above
Key exclusion criteria	1. Exhibited buccal alveolar bone defects, such as dehiscence or fenestration, or experienced loss of the facial bone plate during extraction 2. Had systemic conditions that could impede bone healing 3. Were pregnant at the time of the study 4. Were classified as heavy smokers, defined as those consuming over 10 cigarettes daily
Date of first enrolment	23/08/2023
Date of final enrolment	23/03/2024

Locations

Countries of recruitment

Syria

Study participating centre

Damascus University

Almazzeh highway
Damascus
00000
Syria

Sponsor information

Damascus University
University/education

Almazzeh highway
Damascus
00000
Syria

Phone	+963 (0)113341864
Email	manager@hcsr.gov.sy
Website	http://www.damascusuniversity.edu.sy
"ROR"	https://ror.org/03m098d13

Funders

Funder type

University/education

Damascus University
Government organisation / Universities (academic only)

Alternative name(s): University of Damascus, جَامِعَةُ دِمَشْقَ, DU
Location: Syria

Results and Publications

Intention to publish date	27/08/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication of the research results
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available on request from Dr Ammar Ibrahim (AmmarIbrahimISRCTN@gmail.com) and in the publication related to it after the end of the research. Type of data that will be shared: demographic information (age, gender), location of the tooth to be extracted, clinical and radiographical measurements, photos of clinical procedure.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		06/08/2024	05/08/2025	Yes	No

Editorial Notes

05/08/2025: Publication reference added.
15/07/2024: Study's existence confirmed by Damascus University.